Drugs / 68Ga-DOTATOC
68Ga-DOTATOC
also known as
68Ga-DOTA-tyr3-Octreotide · gallium Ga 68-edotreotide · 68Ga-DOTA-TATE · 68Ga-edotreotide · Ga-68-DOTA-TOC · NETSPOT
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NETSPOT | — | 2016-06-01 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03197012 | Jul 2017 → May 2019 | neuroendocrine neoplasm | Thomas Hope | Completed | No outcome recorded |
| Phase 0 | NCT03001349 | May 2017 → Feb 2021 | meningioma, multiple endocrine neoplasia type 1, neuroendocrine neoplasm, von Hippel-Lindau disease | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03057509 | Nov 2018 → Oct 2019 | carcinoid tumor | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02359500 | Dec 2014 → Jan 2017 | carcinoid tumor | Lale Kostakoglu | Terminated | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06455358 | Feb 2025 → Jun 2028 expected | neuroendocrine neoplasm | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02177773 | Jun 2014 → Aug 2017 | carcinoid tumor, neuroblastoma, paraganglioma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01619865 | Feb 2012 → Aug 2017 | carcinoid tumor, medulloblastoma, neuroblastoma | Sue O'Dorisio | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05183555 | May 2022 → Jun 2024 | infective endocarditis | Central Hospital, Nancy, France | Completed | No outcome recorded |
| Phase 2 | NCT03602911 | Feb 2019 → Apr 2021 | head and neck squamous cell carcinoma | West Virginia University | Completed | No outcome recorded |
| Phase 2 | NCT01869725 | Apr 2013 → Dec 2018 | adult medulloblastoma, childhood medulloblastoma, neuroblastoma, somatostatinoma | Sue O'Dorisio | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06091748 | Feb 2024 → Nov 2025 | digestive system neuroendocrine neoplasm | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03136328 | May 2016 → Mar 2017 | neuroendocrine neoplasm | Montefiore Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02358018 | — | neuroendocrine neoplasm | Memorial Sloan Kettering Cancer Center | No longer available | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | [68Ga]-DOTATOC | “To compare efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan” NCT01869725 ↗9“Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.” NCT06455358 ↗ “[68Ga]-DOTATOC” NCT02359500 ↗ |
| Known as | 68Ga-DOTA-TATE | “This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.” NCT03602911 ↗ |
| Known as | 68Ga-DOTA-tyr3-Octreotide | “68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) PET/CT has been shown to have high accuracy in adults with neuroendocrine tumors, however has not been studied in pediatric patients.” PMID 29181270 ↗ Nov 20172“To compare efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan” NCT01869725 ↗ “[68Ga]-DOTA-tyr3-Octreotide” NCT02359500 ↗ |
| Known as | 68Ga-edotreotide | “For several years, a radiopharmaceutical, 68Ga-DOTATOC (68Ga-edotreotide) has been used in PET/CT for the diagnosis and follow-up of neuroendocrine tumours (NETs).” NCT05183555 ↗ |
| Known as | Ga-68-DOTA-TOC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03057509 ↗ |
| Known as | gallium Ga 68-edotreotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01869725 ↗ |
| Known as | NETSPOT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03602911 ↗ |
| Modality | Peptide | “A number of Ga-68 DOTA-conjugated peptides have been introduced, including Ga-68 DOTA0-Tyr3\]octreotide (Ga-68 DOTATOC), Ga-68 DOTA0-1NaI3-octreotide (Ga-68 DOTANOC) and...” NCT01619865 ↗ |
| Route | Intravenous | “1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.” NCT01619865 ↗ |