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

NCT01967537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2019-11-19

Study results available
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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.

Conditions

Interventions

DRUG

68Gallium DOTATATE

Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

PROCEDURE

Radio-guided surgery

Using 68Gallium DOTATATE

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Naris Nilubol, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-18
Primary Completion
2017-12-17
Completion
2018-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967537 on ClinicalTrials.gov