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68Ga-DOTATATE PET Scan for Neuroendocrine Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Ochsner Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance score greater than 50

Females of childbearing potential must have a negative pregnancy test at screening/baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new way to scan for neuroendocrine cancer, which is often undetected by other methods. The new scan (68Ga-DOTATATE PET) will be compared to regular imaging methods to see if it is more effective.

Who is the study for?

Adults with neuroendocrine tumors or suspected positive tumors, who can consent and have a moderate level of physical function. Women must not be pregnant. Excluded are those with high creatinine or liver enzyme levels, severe allergies to IV contrast, recent use of investigational products, serious illnesses that could affect participation, active infections, inability to stay still for imaging or fit into the scanner due to size.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of a new PET scan using 68Ga-DOTATATE compared to standard imaging methods in detecting neuroendocrine tumors. Patients will receive an injection of this tracer dose radiopharmaceutical for tumor imaging.See study design

What are the potential side effects?

Potential side effects may include reactions related to the intravenous injection such as pain at the injection site or allergic reactions. Since it's an imaging agent used in very low doses for scanning purposes only, significant side effects are uncommon.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to live at home and care for most of my personal needs.

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I am capable of becoming pregnant and have a negative pregnancy test.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary outcome measures

Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques

We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ScanExperimental Treatment1 Intervention

We will perform 68Ga-DOTATATE PET scans on subjects.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor

93 Previous Clinical Trials

184,411 Total Patients Enrolled

Media Library

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. Clinical Trial Eligibility Overview. Trial Name: NCT02038738 — Phase 1 & 2

Carcinoid Syndrome Research Study Groups: Scan

Carcinoid Syndrome Clinical Trial 2023: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. Highlights & Side Effects. Trial Name: NCT02038738 — Phase 1 & 2

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. 2023 Treatment Timeline for Medical Study. Trial Name: NCT02038738 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study actively recruiting participants?

"According to the information on clinicaltrials.gov, this study is not currently admitting any new patients. The onset of this trial was March 1st 2014 and it underwent its most recent update January 16th 2014. Although no fresh participants are being recruited for this particular experiment, there are 2,540 other studies with open enrollment at present."

Answered by AI

Has there ever been an experiment using 68Ga-DOTATATE to observe tumors through Positron Emission Tomography, with only a small amount of the compound being injected?

"Currently, there are 5 trials running for 68Ga-DOTATATE to be delivered through intravenous injections of trace amounts and imaging tumors with Positron Emission Tomography. None of these studies have reached Phase 3 yet; however, they can all be accessed at 7 different medical sites in Rochester, Minnesota."

Answered by AI

What is the maximum capacity of participants for this clinical research?

"This clinical trial has since closed; the initial posting was on March 1st 2014 and it was last edited January 16th. For those hoping to join other studies, there are 2535 apudoma related trials actively recruiting as well as 5 68Ga-DOTATATE studies which utilize tracer doses for imaging tumors via Positron Emission Tomography."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Richard J. Campeau, M.D., FACNM 2014. "68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02038738.

All > Carcinoid Tumor > Neuroendocrine Tumor