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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 is a Phase 1 study that has completed, run by Sue O'Dorisio. The registered enrollment target is 223 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01619865
The ClinicalTrials.gov registry entry for NCT01619865 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sue O'Dorisio, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 68Ga-DOTATOC PET/CT is the first listed.
NCT01619865 reports 0 study locations.
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.
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