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Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

NCT02441062•Sue O'Dorisio

Summary

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

Detailed Description

This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent
•2. Age ≥ 6 months
•3. Histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
•4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO equivalent)
•5. Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. A negative pregnancy test will be required for all female subjects with child bearing potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant. Female must also be non-lactating.

Exclusion Criteria

•1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system.
•2. Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
•3. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
•4. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
•5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT scan.
•6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

January 20, 2020

Completion Date

January 20, 2020

Last Updated

December 21, 2020

Enrollment

122

ACTUAL participants

Conditions

Neuroendocrine TumorsCarcinoid TumorsNeuroblastomaMedulloblastoma

Interventions

68Ga-DOTATOC PET/CT

DRUG

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

NCT05746208

Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

NCT06228066

Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

Inclusion Criteria

Exclusion Criteria

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