Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT03604315

Recruiting

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF

Breast CancerOvarian Cancer

Phase 1

M D Anderson Cancer Center

United States of America

Sponsor: M.D. Anderson Cancer Center

Last Updated: October 14, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

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Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

F-18 Fludeoxyglucose, F-18 Fluorthanatrace

Target

Glucose metabolism, PARP-1

Trial Started

December 18, 2018

Last Updated by Sponsor

October 14, 2025

Estimated Completion

June 30, 2027

Eligibility

Inclusion Criteria

* History of known or suspected solid tumor.

* At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG] PET/CT).

Exclusion Criteria

* 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.

* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll300

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

Computed Tomography
Computed Tomography
Fludeoxyglucose F-18
Fluorine F 18 Fluorthanatrace
Positron Emission Tomography
Positron Emission Tomography

Outcome Measures

Primary Outcome Measures

Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomographyUp to 4 years

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

Secondary Outcome Measures

Incidence of adverse eventsUp to 4 years

BRCA mutation statusUp to 4 years

To determine any correlation with BRCA status, fluorine F 18 fluorthanatrace ([18F]FTT) uptake values (mean and SD) across patient and lesion (summing across lesions) will be summarized, by BRCA status group. Group difference will be tested using t-tests.

PARP-1 activity in tumor tissue samplesUp to 4 years

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and SD across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

Change in fluorine F 18 fluorthanatrace uptake measures after therapyBaseline up to 4 years

Trial Sites

This study has 1 trial site

M D Anderson Cancer Center
Houston, Texas, US

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