NCT06500065

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

July 8, 2024

Last Update Submit

January 29, 2026

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Regions of pathologically increased tracer uptake

    Positron emission tomography (PET) images will be evaluated visually for regions of pathologically increased tracer uptake that could not be attributed to normal physiologic activity. The non-contrast enhanced computed tomography images are used for attenuation correction and for fusion with PET images to allow for anatomical - localization of PET findings.

    At completion of imaging

Secondary Outcomes (1)

  • Incidence of adverse events

    Up to 7 days after completion of imaging

Study Arms (1)

Diagnostic (68Ga-DOTATATE dPET/CT)

EXPERIMENTAL

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..

Procedure: Computed TomographyRadiation: Gallium Ga 68-HA-DOTA-TATEProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo dPET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Diagnostic (68Ga-DOTATATE dPET/CT)
Gallium Ga 68-HA-DOTA-TATERADIATION

Given IV

Also known as: 68Ga-DOTA-3-iodo-Tyr3-octreotate, 68Ga-DOTA-iodoTyr3-octreotate, 68Ga-HA-DOTATATE, [68Ga]DOTA-3-iodo-Tyr3-octreotate, [68Ga]high-affinity DOTATATE
Diagnostic (68Ga-DOTATATE dPET/CT)
Positron Emission TomographyPROCEDURE

Undergo dPET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (68Ga-DOTATATE dPET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

68Ga-DOTA-iodo-Tyr(3)-octreotateMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Gabriel R Tinoco Suarez

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

September 30, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

US(1)