68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas

Last updated: October 29, 2024
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma (Pediatric)

Soft Tissue Sarcoma

Sarcoma

Treatment

Positron Emission Tomography

Computed Tomography

Gallium Ga 68-HA-DOTA-TATE

Clinical Study ID

NCT06500065
OSU-20208
NCI-2020-11528
  • Ages > 18
  • All Genders

Study Summary

This trial studies how well 68Ga-DOTATATE digital PET/CT work in diagnosing soft tissue sarcoma. 68Ga-DOTATATE is a radiotracer that may improve image quality of PET imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. 68Ga-DOTATATE digital PET/CT may work better in imaging patients with soft tissue sarcomas.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients >= 18 years of age

  • Patients diagnosed with any stage of soft tissue sarcomas candidates for systemictherapies

  • Patients with one standard of care PET/CT scan up to 30 days before enrollment atthe Ohio State University facilities.

Exclusion

Exclusion Criteria:

  • Hypersensitivity to somatostatin or similar peptides

  • Somatostatin long-acting analog in the past 6 months

  • Patients who are pregnant or lactating

  • Patients who are currently incarcerated

  • Patients with acute infections

  • Inability to complete the needed investigational and standard-of-care imagingexaminations due to other reasons (severe claustrophobia, radiation phobia, etc.)

  • Patients exceeding the weight limitations of the scanner or are not able to enterthe bore of the dPET/CT scanner due to body mass index (BMI)

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Positron Emission Tomography
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

PRIMARY OBJECTIVE:

I. To assess the feasibility and capability of gallium Ga 68-HA-DOTA-TATE (68Ga-DOTATATE) digital positron emission tomography (dPET)/ computed tomography (CT) imaging for soft tissue sarcomas.

SECONDARY OBJECTIVES:

I. To evaluate the clinical benefit of 68Ga-DOTATATE for a comprehensive assessment of soft tissue sarcomas (STS) using next-generation digital PET detector technology.

II. To describe the perfusion and early tumor uptake kinetics of tumor targets at baseline and following conventional systemic therapy using both 68Ga-DOT AT A TE dPET/CT and 18F-FDG dPET/CT approaches.

III. Using list-mode dPET acquisitions following standard 68Ga-DOTATATE dose administrations, imaging datasets will be retrospectively generated to simulate lower dose or faster image acquisition in order to define further the minimum 68Ga-DOTATATE dose and PET image acquisition times needed to maintain lesion detectability and PET quantification.

V. To assess the feasibility for 68Ga-DOTATATE dPET/CT to identify and stratify STS patients with SSTR2-positive soft tissue sarcoma lesions for future therapy planning using 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) for patients with 68Ga-DOTATATE-avid sarcomas.

VI. To assess the safety of 68Ga-DOTATATE in this patient population.

OUTLINE:

Patients receive gallium Ga 68-HA-DOTA-TATE intravenously (IV) and undergo dPET/CT over 60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and undergo dPET/CT over 60 minutes.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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