Recruiting

68Ga-DOTATATE

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06500065

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Gallium Ga 68-HA-DOTA-TATE

Positron Emission Tomography

Study Details

Brief 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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT06500065

Start date

Sep 30, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients >= 18 years of age
  • Patients diagnosed with any stage of soft tissue sarcomas candidates for systemic therapies
  • Patients with one standard of care PET/CT scan up to 30 days before enrollment at the Ohio State University facilities.

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 imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the dPET/CT scanner due to body mass index (BMI)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (68Ga-DOTATATE dPET/CT)

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..

Interventions

Computed Tomography

Undergo dPET/CT

Gallium Ga 68-HA-DOTA-TATE

Given IV

Positron Emission Tomography

Undergo dPET/CT

Primary outcome measure

  • Regions of pathologically increased tracer uptake [ Time Frame: At completion of imaging ]

Central Contacts and Locations

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Gabriel R. Tinoco Suarez

614-293-0109Gabriel.Tinoco@osumc.edu

Principal Investigator:

Gabriel R. Tinoco Suarez

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-02-02.