Tracers / [68Ga]Ga-DOTA-TOC
[68Ga]Ga-DOTA-TOC
Also written as [68Ga]DOTATOC; [68Ga]Ga-DOTA-TOC; [68Ga]Ga-DOTATOC; [Ga-68]DOTATOC; [Ga-68]Ga-DOTA-TOC; [Ga-68]Ga-DOTATOC; DOTA-TOC
- Radionuclide
- Ga-68 t½ 67.71 min
- Modality
- PET
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 86
What it is
- Compound class
- Radiolabelled somatostatin analogue peptide (octreotide/DOTA-Tyr3-octreotide derivative)
- Target / mechanism
- Somatostatin receptor, predominantly subtype 2 (SSTR2) PMID 29243585
- Clinical application
- PET imaging of somatostatin-receptor-expressing neuroendocrine tumours (NET) PMID 29243585
- Theranostic pair
- <a href="/tracers/lu177-dotatoc/">lu177-dotatoc</a>
Regulatory status
- FDA
- 2019, Gallium Ga 68 Edotreotide Injection, University of Iowa Health Care (UIHC) PET Imaging FDA (Drugs@FDA/openFDA): NDA210828, approved 2019-08-21
- EMA (centralised)
- 2016, SomaKit TOC, Advanced Accelerator Applications (Novartis group) EMA medicines register export (2026-09-09): EMEA/H/C/004140, 'Authorised'; date of authorisation 8 Dec 2016 (EMA EPAR overview)
- Other approvals
- —
- Brand names
- Gallium Ga 68 Edotreotide (US); SomaKit TOC (EU)
Clinical use
- Typical injected activity
- —
- Uptake time
- —
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| iMiDEV PMB-Alcen | vendor cassette | SPE | 46 ± 7 yes | 99.6 ± 0.2% (HPLC) | DOTA-TOC MedChemTronica, Sollentuna, Sweden | 38091157 2023 EJNMMI Radiopharm Chem Microfluidic-based production of [68Ga]Ga-FAPI-46 and [68Ga]Ga-DOTA-TOC using the cassette-based iMiDEV™ microfluidic radiosynthesizer — For [68Ga]Ga-DOTA-TOC, RCYdc was 46 ± 7% (n = 3) |
| Scintomics GRP / GRP-3V Scintomics | — | SPE | — | — | DOTATOC ABX | 32410136 2020 EJNMMI Radiopharm Chem The syntheses were performed using a GRP® synthesis module from Scintomics (Fürstenfeldbruck, Germany) with the cationic concentration protocol provided by Scintomics. |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | 64% | >95% | DOTATOC ABX | 34439784 2021 Biomolecules Automated radiosynthesis was performed on an Eckert & Ziegler Modular-Lab PharmTracer synthesis module using the Modular-Lab software (Eckert & Ziegler). — RCYs of 57% and 64% were obtained for [68Ga]Ga-FAPI-46 and [68Ga]Ga-DOTATOC, respectively. |
| FASTlab GE HealthCare | — | SPE | 54.03±2.45 yes | 97.86±0.51 | DOTATOC BCN Peptides, Barcelona, Spain | 25369268 2014 PLoS One Most of the synthesis was performed using an automated process programmed in a FastLab module (General Electric Healthcare). — the decay-corrected radiochemical yield (%) was 54.03±2.45, 66.13±3.35 and 67.81±3.12 |
| — | — | — | — | — | — | 28529632 2017 Theranostics |
| Scintomics (model not stated) Scintomics | — | — | — | — | — | 26843617 2016 Oncotarget [68Ga]DOTATOC was prepared using a modification of the method described by Breeman et al. [24] using a SCINTOMICS radiotracer synthesis module (Scintomics, Fürstenfeldbruck, Germany). |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 82.2 ± 2.7% yes | 97.3 ± 0.0% | DOTATOC (Edotreotide) MedChemExpress | 41011146 2025 Pharmaceuticals (Basel) A Scintomics GRP-3V module (Scintomics, Fürstenfeldbruck, Germany) was used for the automated synthesis of [68Ga]Ga-DOTATOC in combination with a 2-bench cassette system — an average decay-corrected yield (d.c.y.) of 82.2 ± 2.7% based on the theoretical maximum gallium-68 activity of the generator at that time point |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 88.3 ± 0.6% yes | 97.8 ± 1.3% | DOTATOC (Edotreotide) MedChemExpress | 41011146 2025 Pharmaceuticals (Basel) A Scintomics GRP-3V module (Scintomics, Fürstenfeldbruck, Germany) was used for the automated synthesis of [68Ga]Ga-DOTATOC in combination with a 2-bench cassette system — corresponding to an average decay-corrected yield of 88.3 ± 0.6% |
| — | — | SPE | 34.4 ± 21.3% (0.6 nmol) yes | — | DOTATOC Bachem, Bubendorf, Switzerland | 22682112 2012 EJNMMI Res |
| — | — | — | — | — | — | 34294854 2021 Sci Rep |
| FASTlab 2 GE HealthCare | custom manifold | HPLC | 48.9 yes | 97.98 | Ga-DOTATOC acetate ABX | 40353471 2025 Curr Radiopharm the synthesis of [68Ga]Ga-DOTA-TOC was performed by FASTlab2 developer system — achieving a synthesis yield percentage (corrected for decay) of an average value of 48.9% |
| Kit-based preparation Advanced Accelerator Applications | vendor cassette | — | — | — | edotreotide (Somakit TOC) Advance Accelerator Applications, Italy | 40353471 2025 Curr Radiopharm 5 mL of [68Ga]GaCl3 was eluted through metal-free materials into a Somakit TOC® (40 mg of edotreotide) vial (Advance Accelerator Applications, Italy) |
| iQS-TS ITG (Isotope Technologies Garching) | vendor cassette | SPE | 62.6 | 99.1 | DOTATOC | 34658552 2021 Indian J Nucl Med Hot cell to house 68Ga iQS-TS Synthesis module, ITG, Germany — The average % synthesis yield and average % radiochemical purity obtained over all the synthesis were 62.6 (±2.3) and 99.1 (±0.2) %, respectively |
| — | — | — | — | — | — | 42591815 2026 Gland Surg |
| Kit-based preparation Novartis | vendor cassette | — | — | 98.9 ± 0.7% by rTLC; 93.1 ± 1.4% by rHPLC | edotreotide Novartis | 42344682 2026 World J Nucl Med Radiolabeling experiments were conducted using commercial SOMAKIT-TOC (edotreotide) kits. |
| Kit-based preparation Novartis | vendor cassette | — | — | 98.9 ± 1.1% by rTLC; 91.6 ± 1.0% by rHPLC | edotreotide Novartis | 42344682 2026 World J Nucl Med a full kit vial was reconstituted with 2 mL of WFI... two 68 Ge/ 68 Ga generators were connected to the kit vial and eluted sequentially, directly into the vial |
| Kit-based preparation Novartis | vendor cassette | — | — | Aliquot1: 99.0 ± 0.6% rTLC, 91.1 ± 3.4% rHPLC; Aliquot2: 97.6 ± 0.9% rTLC, 90.8 ± 2.3% rHPLC | edotreotide Novartis | 42344682 2026 World J Nucl Med a kit vial was reconstituted with 6.2 mL of WFI... to obtain two equal aliquots. The first radiolabeling was performed immediately on one aliquot, following the steps described in Procedure 1. |
| Kit-based preparation Novartis | vendor cassette | — | — | Aliquot1: 95.6 ± 1.4% rTLC, 87.2 ± 3.4% rHPLC; Aliquot2: 97.2 ± 3.4% rTLC, 89.6 ± 3.0% rHPLC | edotreotide Novartis | 42344682 2026 World J Nucl Med the kit vial was reconstituted and divided into two aliquots as described in Procedure 3. Both aliquots were then radiolabeled on the same day... using the two-generator preparation method detailed in Procedure 2. |
| — | — | — | — | — | — | 42141279 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42048552 2026 Eur Heart J Cardiovasc Imaging |
| — | — | — | — | — | — | 41894844 2026 Endocrinol Diabetes Metab Case Rep |
| — | — | — | — | — | — | 41886137 2026 Curr Treat Options Oncol |
| Scintomics GRP / GRP-3V | vendor cassette | SPE | 62 | >98% for 68Ga-DOTATOC | DOTA0-(Phe1-Tyr3)-octreotide | 41824275 2026 EJNMMI Radiopharm Chem an automated synthesis module (Scintomics GRP®, Fürstenfeldbruck, Germany) — assuming a reference radiolabelling yield of 62% |
| — | — | — | — | — | — | 41693498 2026 Nucl Med Commun |
| — | — | — | — | — | — | 41210494 2025 Front Endocrinol (Lausanne) |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 82.2 ± 2.7% yes | 97.3 ± 0.0% | DOTATOC (Edotreotide) MedChemExpress | 41011146 2025 Pharmaceuticals (Basel) A Scintomics GRP-3V module (Scintomics, Fürstenfeldbruck, Germany) was used for the automated synthesis of [68Ga]Ga-DOTATOC — average decay-corrected yield (d.c.y.) of 82.2 ± 2.7% |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 88.3 ± 0.6% yes | 97.8 ± 1.3% | DOTATOC (Edotreotide) MedChemExpress | 41011146 2025 Pharmaceuticals (Basel) A Scintomics GRP-3V module (Scintomics, Fürstenfeldbruck, Germany) was used for the automated synthesis of [68Ga]Ga-DOTATOC — corresponding to an average decay-corrected yield of 88.3 ± 0.6% |
| Manual synthesis | — | SPE | 60.81 ± 1.96% | >97% | DOTATOC acetate (precursor D) / DOTATOC acetate salt (precursor E) ABX | 40941986 2025 Molecules DOTA-TOC precursor in 1 mL acetate buffer was added to a vial containing about 5 mL of gallium-68 chloride. The reaction mixture was placed in a heating block preheated to 95 °C and heated for 10 min. — The obtained yields were 60.81 ± 1.96% for the first precursor and 54.15 ± 0.40% for the second |
| Kit-based preparation Novartis | vendor cassette | none | 54.15 ± 0.40% | >97% | SomaKit TOC Novartis | 40941986 2025 Molecules The labeling procedure of the precursor F was performed according to the standard kit manufacturer’s instruction. — The obtained yields were 60.81 ± 1.96% for the first precursor and 54.15 ± 0.40% for the second |
| — | — | — | — | — | — | 40598690 2025 Cancer Imaging |
| — | — | — | — | — | — | 40455253 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40453587 2025 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 40445313 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40361414 2025 Cancers (Basel) |
| miniAllinOne Trasis | vendor cassette | — | — | 99.21% | EDOTREOTIDE (DOTA-TOC) Advanced Accelerator Applications, Rueil-Malmaison, France | 40358768 2025 EJNMMI Radiopharm Chem Radiolabeling was carried out using the automated synthesizer MiniAiO® (Trasis SA, Ans, Belgique) |
| FASTlab 2 GE HealthCare | custom manifold | HPLC | 48.9 yes | 97.98 | Ga-DOTATOC acetate ABX | 40353471 2025 Curr Radiopharm the synthesis of [68Ga]Ga-DOTA-TOC was performed by FASTlab2 developer system according to the Guidelines on Good Radiopharmacy Practice (cGRPP) — with a decay-corrected yield (time of synthesis: 40 minutes) from an average minimum of 45.1% to a maximum of 52.5% (Mean: 48.9%) |
| Kit-based preparation Advanced Accelerator Applications | — | — | — | — | Somakit TOC (edotreotide) Advance Accelerator Applications, Italy | 40353471 2025 Curr Radiopharm Following the Somakit TOC® SmPC (Summary of Product Characteristics), 5 mL of [68Ga]GaCl3 was eluted through metal-free materials into a Somakit TOC® (40 mg of edotreotide) vial (Advance Accelerator Applications, Italy) |
| — | — | — | — | — | — | 39878896 2025 Eur J Nucl Med Mol Imaging |
| FASTlab 2 GE HealthCare | custom manifold | none | — | 97.81 | DOTA-(Tyr3)-octreotide acetate (DOTA-TOC) Fischer Scientific | 39598846 2024 Molecules Automated labeling of the precursor was accomplished using a FASTLab 2 synthesizer. |
| — | — | — | — | — | — | 39579473 2024 Endocr Connect |
| — | — | — | — | — | — | 39538188 2024 BMC Endocr Disord |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | — | — | — | DOTA-TOC piCHEM, Raaba-Grambach, Austria | 39464654 2024 Front Nucl Med [68Ga]Ga-DOTA-TOC was synthesized in an automatic Modular-Lab Pharm Tracer module connected to a 68Ge/68Ga-generator IGG100 (Eckert & Ziegler), following the synthesis template and kit reagents of the manufacturer. |
| — | — | — | — | — | DOTATOC | 39142827 2024 J Nucl Med |
| — | — | — | — | — | — | 38788146 2024 Arch Endocrinol Metab |
| — | — | — | — | — | — | 38697682 2024 BMJ Case Rep |
| Manual synthesis | — | SPE | 78 ± 15% | >99% | DOTA-TOC | 38675474 2024 Pharmaceuticals (Basel) [68Ga]Ga-DOTA-TOC was synthesized with slight modifications of the described production method [32,33]. — Radiochemical yield was 78 ± 15% (n = 5) |
| — | — | — | — | — | — | 38403723 2024 Eur J Nucl Med Mol Imaging |
| Manual synthesis | — | SPE | — | — | DOTA-TOC | 38346097 2024 J Med Chem Identical procedures were used to synthesize 68Ga-DOTA-TOC as the positive control. |
| iMiDEV PMB-Alcen | vendor cassette | SPE | 46 ± 7% yes | 99.6 ± 0.2% (HPLC) | DOTA-TOC MedChemTronica, Sollentuna, Sweden | 38091157 2023 EJNMMI Radiopharm Chem Microfluidic cassette-based iMiDEV™ radiosynthesizer — For [68Ga]Ga-DOTA-TOC, RCYdc was 46 ± 7% (n = 3) |
| — | — | — | — | — | — | 37767685 2023 Endocrinol Diabetes Metab Case Rep |
| — | — | — | — | — | — | 36354685 2022 Curr Issues Mol Biol |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | — | — | DOTATOC ABX | 35889351 2022 Molecules the automated synthesis module Scintomics GRPTM (Scintomics GmbH, Fürstenfeldbruck, Germany) |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | — | — | — | — | 34822040 2021 EJNMMI Res 68Ga-DOTATOC was produced using an automated synthesis platform (Modular PharmLab, Eckert & Ziegler, Germany) equipped with a disposable cassette system (C4-Ga68-PP). |
| Kit-based preparation Advanced Accelerator Applications | vendor cassette | — | — | 98.82% | DOTATOC Advanced Accelerator Applications | 32188715 2020 ESMO Open 68Ga-DOTATOC was prepared on the day of the administration using as the reaction vial containing a lyophilised formulation of 40 µg of DOTATOC (vial 1) to be radiolabelled with 68GaCl3 |
| Manual synthesis | — | none | — | >95% | DOTA-TOC ABX | 31123943 2019 EJNMMI Res A solution of 68Ga(OAc)3 in acetate buffer was added to 20 nmol of each peptide. The reaction mixture was shaken for 10 min at 80 °C to afford [68Ga]Ga-DOTA-TOC or at 20 °C for 10 min to afford [68Ga]Ga-DATA-TOC. |
| — | — | — | — | — | — | 30510849 2018 Am J Nucl Med Mol Imaging |
| Manual synthesis | — | HPLC+SPE | 61% yes | >98% | DOTATOC In-house / non-commercial (various) | 29503845 2017 EJNMMI Radiopharm Chem heated in a microwave oven (catalog number: DMW7700WDB, Danby Appliance, Findlay, Ohio) — 61 ± 5, 62 ± 8 and 68 ± 13% respectively, n = 3 |
| Scintomics (model not stated) Scintomics | — | — | — | — | — | 26843617 2016 Oncotarget [68Ga]DOTATOC was prepared using a modification of the method described by Breeman et al. [24] using a SCINTOMICS radiotracer synthesis module (Scintomics, Fürstenfeldbruck, Germany). |
| FASTlab GE HealthCare | — | SPE | 54.03 yes | 97.86 | DOTATOC BCN Peptides, Barcelona, Spain | 25369268 2014 PLoS One Most of the synthesis was performed using an automated process programmed in a FastLab module (General Electric Healthcare). — the decay-corrected radiochemical yield (%) was 54.03±2.45, 66.13±3.35 and 67.81±3.12 |
| Scintomics (model not stated) Scintomics | — | — | — | — | — | 24742330 2014 BMC Cancer 68Ga-DOTATOC/68Ga-DOTATATE was prepared using a modification of the method described by Breeman et al. [25] using a radiotracer synthesis module (Scintomics, Fürstenfeldbruck, Germany). |
| — | — | — | — | — | — | 23522791 2013 Appl Radiat Isot |
| — | — | HPLC | 64.68 | 98 ± 0.22% | DOTATOC | 35190517 2022 Nucl Med Commun |
| — | — | none | greater than 80% | — | DOTATOC | 22755505 2012 Bioconjug Chem The NaCl method was further evaluated using an automated fluid handling system — radiochemical yields greater than 80% |
| — | — | none | in excess of 65% | greater than 99% | DOTATOC | 22755505 2012 Bioconjug Chem The NaCl method was further evaluated using an automated fluid handling system and it routinely facilitates radiochemical yields in excess of 65% in less than 15 min, with radiochemical purity consistently greater than 99% for the preparation of (68)Ga-DOTATOC. — routinely facilitates radiochemical yields in excess of 65% in less than 15 min |
| — | — | — | — | — | — | 22336375 2012 Nucl Med Biol |
| — | — | SPE | about 60% yes | — | DOTA-Tyr-octreotide (DOTATOC) | 17901771 2007 Nucl Med Commun A fully automated radiopharmaceutical synthesis device based on a modular concept for remote-controlled processing was developed and evaluated for a number of DOTA-derivatized peptides. — Automated synthesis resulted in overall decay-corrected reaction yields of about 60% within 10 min. |
| — | — | — | — | — | DOTA-TOC | 31845408 2020 J Labelled Comp Radiopharm utilizing a cassette module (GAIA; Elysia-Raytest; Germany) with a manual setup |
| — | — | — | — | — | DOTA-TOC | 31845408 2020 J Labelled Comp Radiopharm manual setup for routine clinical production |
| — | — | — | — | — | Somakit TOC | 30636620 2019 Curr Radiopharm Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product |
| — | — | — | — | — | Somakit TOC | 30636620 2019 Curr Radiopharm Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC |
| — | — | — | — | — | Somakit TOC | 30636620 2019 Curr Radiopharm 28±0.5 minutes for the semi-automated |
| — | — | SPE | 54.4 ± 2.3 % | 96.94 ± 0.74 % | DOTA-TOC | 29745348 2018 Curr Radiopharm We reported the [68Ga]Ga-DOTA-TOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification. — The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the radiochemical purity average was found 96.94 ± 0.74 %. |
| — | — | — | >80% | >98% | DOTATOC | 27103024 2016 J Nucl Med the generator system is contained within the fluidic labeling module — greater than 80% radiochemical yield |
| — | — | — | — | — | — | 42554825 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42350034 2026 J Nucl Med |
| — | — | — | — | — | — | 42257554 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41699279 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 34740949 2022 J Nucl Med |
| — | — | — | — | — | — | 32149792 2020 Clin Nucl Med |
| — | — | — | — | — | — | 31806775 2020 J Nucl Med |
| — | — | — | — | — | — | 31764593 2020 Nucl Med Commun |
| — | — | — | — | — | — | 31520872 2019 Nucl Med Biol |
| — | — | — | — | — | — | 31302632 2020 J Nucl Med |
| — | — | — | — | — | — | 29191855 2018 J Nucl Med |
| — | — | — | — | — | — | 23370092 2013 Q J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 23151915 2013 Eur J Nucl Med Mol Imaging |
Precursor
- Common precursor
- DOTA-TOC PMID 38091157 (DOI 10.1186/s41181-023-00229-9)
- Suppliers seen in the literature
- MedChemTronica (Sollentuna, Sweden)
- Cited suppliers in indexed syntheses
- ABX, Advance Accelerator Applications, Advanced Accelerator Applications, Advanced Accelerator Applications, Rueil-Malmaison, BCN Peptides, Bachem, Bubendorf, Fischer Scientific, In-house / non-commercial (various), MedChemExpress, MedChemTronica, Sollentuna, Novartis, piCHEM
- Typical final purification
- SPE
Need this precursor?We can point you to suppliers for [68Ga]Ga-DOTA-TOC, or handle the enquiry for you.
Get in touchQuality control Pharmacopoeial monograph
- Ph. Eur. monograph
- 2482
- USP monograph
- not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. Base set per Ph. Eur. 0125 + monograph 2482. Ge-68 breakthrough + metal impurities: generator Ga-68 only. RECOMMEND ADD: molar activity / peptide content (saturable target).
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [68Ga]Ga-DOTA-TOC.
Get in touchNotes
Added from reverse module search (stage 6); 26 article(s) with Ga-68. Also seen with Cu-61[1], Ga-67[1], Tb-161[1], Y-90[1] (too few articles for own row).