NCT06500065

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

Clinical Feasibility and Potential Clinical Benefit of 68Ga-DOTATATE PET/CT Assessment of Soft Tissue Sarcomas for Potential Peptide Receptor Radionuclide Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo dPET/CT
RADIATION	Gallium Ga 68-HA-DOTA-TATE	Given IV
PROCEDURE	Positron Emission Tomography	Undergo dPET/CT

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-07-15
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study