Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06500065

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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-02

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 68Ga-DOTATATE digital PET/CT imaging in diagnosing soft tissue sarcomas. This study aims to assess the feasibility and potential clinical benefits of this imaging method, which may improve image quality compared to existing PET techniques. It also explores tumor uptake kinetics and the possibility of using imaging results to plan future peptide receptor radionuclide therapy for patients with specific tumor types. Participants receive an intravenous injection of gallium Ga 68-HA-DOTA-TATE and undergo digital PET/CT scanning for 60 minutes within two weeks after starting standard chemotherapy. About 24 hours later, they are given a fludeoxyglucose F-18 injection, followed by another 60-minute digital PET/CT scan. The study uses advanced PET detector technology to evaluate tumor characteristics and simulate imaging with lower doses or faster acquisition times. During the study, participants undergo imaging assessments to measure regions with increased tracer uptake. Researchers monitor safety by tracking adverse events up to seven days after imaging. The study involves standard chemotherapy alongside the imaging procedures. The total participation duration varies but includes the imaging sessions around chemotherapy and safety follow-up shortly after. This research is sponsored by Ohio State University Comprehensive Cancer Center.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Diagnosed with any stage of soft tissue sarcomas and candidates for systemic therapies
  • Have had one standard of care PET/CT scan within 30 days prior to enrollment at the study site
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to somatostatin or similar peptides
  • Use of somatostatin long-acting analogs within the past 6 months
  • Pregnant or breastfeeding women
  • Currently incarcerated individuals
  • Patients with acute infections
  • Unable to complete investigational or standard imaging due to claustrophobia, radiation phobia, or other reasons
  • Patients exceeding the weight limits or unable to fit in the PET/CT scanner due to body size

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 weeks after starting standard chemotherapy

Participants receive gallium Ga 68-HA-DOTA-TATE intravenously and undergo digital PET/CT imaging over 60 minutes up to two weeks after starting standard chemotherapy. About 24 hours after this imaging, participants receive fludeoxyglucose F-18 intravenously and undergo another digital PET/CT over 60 minutes.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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