Impact of 68Ga-DOTATATE PET/CT on the Management of Neuroendocrine Tumors: The Referring Physician's Perspective

July 17, 2024 updated by: Jonsson Comprehensive Cancer Center
Somatostatin receptor imaging with 68Ga-DOTATATE PET/CT (DOTATATE) is increasingly used for managing patients with neuroendocrine tumors. The objective of this study was to determine referring physicians' perspectives on the impact of DOTATATE on the management of neuroendocrine tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Somatostatin receptor imaging with 68Ga-DOTATATE PET/CT (DOTATATE) is increasingly used for managing patients with neuroendocrine tumors. The objective of this study was to determine referring physicians' perspectives on the impact of DOTATATE on the management of neuroendocrine tumors. Methods: A set of 2 questionnaires (pre-PET and post-PET) was sent to the referring physicians of 100 consecutive patients with known or suspected neuroendocrine tumors, who were evaluated with DOTATATE. Questionnaires on 88 patients were returned (response rate, 88%). Referring physicians categorized the DOTATATE findings on the basis of the written PET reports as negative, positive, or equivocal for disease. The likelihood for metastatic disease was scored as low, moderate, or high. The intended management before and changes as a consequence of the PET study were indicated. Results: The indications for PET/CT were initial and subsequent treatment strategy assessments in 14% and 86% of patients, respectively. Referring physicians reported that DOTATATE led to a change in suspicion for metastatic disease in 21 patients (24%; increased and decreased suspicion in 9 [10%] and 12 [14%] patients, respectively). Intended management changes were reported in 53 of 88 (60%) patients. Twenty patients (23%) scheduled to undergo chemotherapy were switched to treatments without chemotherapy, and 6 (7%) were switched from watch-and-wait to other treatment strategies. Conversely, 5 patients (6%) were switched from their initial treatment strategy to watch-and-wait. Conclusion: This survey of referring physicians demonstrates a substantial impact of DOTATATE on the intended management of patients with neuroendocrine tumors.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Early Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence.
  • At least 18 years of age.
  • Patient or patient's legally acceptable representative cognitively provides written informed consent.
  • Able to provide informed consent.
  • Females of childbearing potential must have a negative pregnancy test at screening/baseline.

Exclusion Criteria:

  • Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
  • Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
  • Inability to lie still for the entire imaging time.
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Recognized concurrent active infection.
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT with one-time administration of 68Ga-DOTATATE
Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study. Scans will be performed with oral and IV contrast. The physicians of patient's receiving a 68Ga-DOTATATE PET/CT will be asked to fill out 2 questionnaires with questions pertaining to the patient's medical management. One questionnaire will be sent before the scan, and one shortly after the scan was performed and the results reported to the referring physician.
Drug: 68Ga-DOTATATE
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
Other Names:
  • 68Ga-DOTATATE PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intended management of patients with NETs after PET/CT
Time Frame: Before the first scan and after the second scan and results reported
The study will collect questionnaire data from referring physicians on intended patient management before and after PET/CT.
Before the first scan and after the second scan and results reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques
Time Frame: 3 Years
We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Johannes Czernin, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2013

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

June 16, 2017

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimated)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001920
  • NCI-2016-01796 (Other Identifier: CTRP)
  • 68Ga-DOTATATE PET/CT (Other Identifier: Jonsson Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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