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NCT01967537 · ClinicalTrials.gov registry record · Phase 2

Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
341
Enrollment target

NCT01967537: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01967537 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 341 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01967537, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
341 participants
Enrollment target

Study Summary

Background: \- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs. Objectives: \- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas. Eligibility: \- Adults over 10 years old with a suspected NET or family history of NET. Design: * Participants will be screened with a medical history and physical exam, and have a blood test. * Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images. * A standard computed tomography (CT) scan of the chest, abdomen, and pelvis. * An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT. * A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes. * Researchers will compare images from the three scans. * Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.

Interventions

  • DRUG 68Gallium DOTATATE
  • PROCEDURE Radio-guided surgery

Trial Details

FieldValue
Enrollment Target 341 participants
Start Date 2013-10-18
Est. Completion 2018-03-12
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01967537

The ClinicalTrials.gov registry entry for NCT01967537 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 341 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 68Gallium DOTATATE is the first listed.

NCT01967537 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01967537 about?

NCT01967537 is a clinical study titled "Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors". Background: \- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. T...

What is the current status of trial NCT01967537?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 341 participants. The study started on 2013-10-18. Estimated completion is 2018-03-12.

What interventions are being tested in trial NCT01967537?

The interventions under investigation include: 68Gallium DOTATATE (DRUG), Radio-guided surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01967537?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.