Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01619865 · ClinicalTrials.gov registry record · Phase 1
Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors
A Phase 1 study, sponsored by Sue O'Dorisio.
- Completed
- Registry status
- Phase 1
- Development phase
- 223
- Enrollment target
NCT01619865: Completed Phase 1 study, sponsored by Sue O'Dorisio.
NCT01619865 is a Phase 1 study that has completed, run by Sue O'Dorisio. The registered enrollment target is 223 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (272% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619865, a Phase 1 study, has completed, sponsored by Sue O'Dorisio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 223 participants
- Enrollment target
Study Summary
This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
Primary Outcome
Subject receives an injection of 68Ga-DOTATOC, a somatostatin-like peptide that binds to somatostatin receptor and is tagged with a radionuclide that can be detected by positron emission tomography (PET). Whole body PET is performed; patient is queried regarding any adverse events immediately and again 24 hrs after completion of scan read by certified nuclear medicine physician to determine if any known tumor lesions take up 68Ga-DOTATOC.Severity of adverse events will be graded according to NCI
Interventions
- DRUG 68Ga-DOTATOC PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2017-08-27 |
| Phase | Phase 1 |
What the finished NCT01619865 record still lists
NCT01619865 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (272% higher).
The record links to 0 conditions, and to 1 intervention - of which 68Ga-DOTATOC PET/CT is the first listed.
NCT01619865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01619865 about?
NCT01619865 is a clinical study titled "Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors". This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Oc...
What is the current status of trial NCT01619865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 223 participants. The study started on 2012-02-21. Estimated completion is 2017-08-27.
What interventions are being tested in trial NCT01619865?
The interventions under investigation include: 68Ga-DOTATOC PET/CT (DRUG).
Who is sponsoring clinical trial NCT01619865?
This trial is sponsored by Sue O'Dorisio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01619865's enrollment target sits among peer trials
223 228th of 2000 higher than 1,772 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06640803 · 223 participants · NA
Sacramento Clinical High Risk for Psychosis Stepped-Care Program
- NCT07175285 · 223 participants
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
- NCT07205718 · 223 participants · Phase 1
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
- NCT02706561 · 224 participants · NA
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI