68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas
NCT ID: NCT06500065
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-09-30
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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..
Computed Tomography
Undergo dPET/CT
Gallium Ga 68-HA-DOTA-TATE
Given IV
Positron Emission Tomography
Undergo dPET/CT
Interventions
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Computed Tomography
Undergo dPET/CT
Gallium Ga 68-HA-DOTA-TATE
Given IV
Positron Emission Tomography
Undergo dPET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Gabriel Tinoco
Principal Investigator
Principal Investigators
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Gabriel R Tinoco Suarez
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2020-11528
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-20208
Identifier Type: -
Identifier Source: org_study_id
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