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

NCT ID: NCT01873248

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-26
• Study Completion Date: 2017-06-16

Brief Summary

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.

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68Ga-DOTATATE

Intervention Type: DRUG

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.

Interventions

68Ga-DOTATATE

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.

Intervention Type: DRUG

Other Intervention Names

68Ga-DOTATATE PET/CT scan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Czernin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology

Los Angeles, California, United States

Countries

United States

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Related Links

http://www.pet.ucla.edu

Ahmanson Imaging Division

http://www.pharmacology.ucla.edu

Department of Molecular and Medical Pharmacology UCLA

Other Identifiers

68Ga-DOTATATE PET/CT

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2016-01796

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-001920

Identifier Type: -

Identifier Source: org_study_id