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Radiotracer

68Ga-DOTATATE PET/CT for Soft Tissue Sarcoma

N/A

Recruiting

Led By Gabriel R Tinoco Suarez

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be 18 years of age or older

Be older than 18 years old

Must not have

Patients with acute infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days after completion of imaging

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how well a new imaging technique called 68Ga-DOTATATE digital PET/CT can help in diagnosing soft tissue sarcoma. This technique uses a radiotracer

Who is the study for?

This trial is for individuals with soft tissue sarcoma. Participants should be suitable candidates for PET/CT imaging and have no health conditions that would interfere with the use of the radiotracer 68Ga-DOTATATE or the imaging process.

What is being tested?

The trial is testing how effective a new type of digital PET/CT scan using a radiotracer called 68Ga-DOTATATE is in diagnosing soft tissue sarcomas, potentially offering clearer images than current methods.

What are the potential side effects?

While not explicitly listed, side effects may include reactions to the tracer like rash or itching, discomfort from lying still during scanning, and exposure to radiation typical for PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have an acute infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at completion of imaging

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at completion of imaging

This trial's timeline: 3 weeks for screening, Varies for treatment, and at completion of imaging for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Regions of pathologically increased tracer uptake

Secondary study objectives

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (68Ga-DOTATATE dPET/CT)Experimental Treatment3 Interventions

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..

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790