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NCT03206060 · ClinicalTrials.gov registry record · Phase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
A Phase 2 study of Neuroendocrine Tumors and Pheochromocytoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT03206060 is a Phase 2 study of Neuroendocrine Tumors and Pheochromocytoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 130 participants, below the 177-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03206060, a Phase 2 study of Neuroendocrine Tumors and Pheochromocytoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.
Conditions Studied
Interventions
- DRUG Lu-177-DOTATATE
- DRUG Ga-68-DOTATATE
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2033-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03206060
The ClinicalTrials.gov registry entry for NCT03206060 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (27% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 2 interventions - of which Lu-177-DOTATATE is the first listed.
NCT03206060 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03206060 about?
NCT03206060 is a clinical study titled "Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma". Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. ...
What is the current status of trial NCT03206060?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2017-10-10. Estimated completion is 2033-01-01.
What conditions does trial NCT03206060 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma, Neuroendocrine Neoplasms.
What interventions are being tested in trial NCT03206060?
The interventions under investigation include: Lu-177-DOTATATE (DRUG), Ga-68-DOTATATE (DRUG).
Who is sponsoring clinical trial NCT03206060?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03206060 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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