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[^18F] FLuorthanatrace PET/CT for Ovarian Cancer

Phase 1

Recruiting

Led By Lilie L Lin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

History of known or suspected solid tumor.

Be older than 18 years old

Must not have

Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential < 2 weeks prior to screening as standard of care.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses PET/CT scans with a radioactive tracer to find ovarian, fallopian tube, or primary peritoneal cancer cells.

Who is the study for?

This trial is for patients with solid tumors, such as ovarian, fallopian tube, or primary peritoneal cancer. Participants must have at least one tumor lesion of 1.0 cm visible on standard imaging. Pregnant or breastfeeding women and those unable to tolerate imaging procedures are excluded.

What is being tested?

The study tests how well a radioactive tracer called Fluorine F 18 fluorthanatrace works in PET/CT scans for detecting tumor cells in various cancers. It's a phase I trial focused on the effectiveness of this novel radiotracer in detailed body imaging.

What are the potential side effects?

As this is an imaging study using a radioactive tracer, potential side effects may include reactions to the tracer like rash or itching, discomfort from the PET/CT procedure, and exposure to radiation.

Eligibility Criteria

Inclusion Criteria

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

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I have or might have had a solid tumor in the past.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography

Secondary study objectives

BRCA mutation status

PARP-1 activity in tumor tissue samples

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: Treatment (FDG PET/CT, [18F]FTT PET/CT)Experimental Treatment4 Interventions

Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo \[18F\]FTT PET/CT over 1 hour.

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

~2740