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

Phase

Condition

Ovarian Cysts

Cancer/tumors

Fallopian Tube Cancer

Treatment

Fluorine F 18 Fluorthanatrace

Computed Tomography

Positron Emission Tomography

Clinical Study ID

NCT03604315

2017-0319

NCI-2018-01137

2017-0319

R01CA249329

Ages > 18
Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

History of known or suspected solid tumor.
At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computedtomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG]PET/CT).

Exclusion

Exclusion Criteria:

Females who are pregnant or breast feeding at the time of screening will not beeligible for this study; a urine pregnancy test will be performed in women ofchild-bearing potential < 2 weeks prior to screening as standard of care.
Inability to tolerate imaging procedures in the opinion of an investigator ortreating physician.
Any current medical condition, illness, or disorder as assessed by medical recordreview and/or self-reported that is considered by a physician investigator to be acondition that could compromise participant safety or successful participation inthe study.

Study Design

Fluorine F 18 Fluorthanatrace

December 18, 2018

June 30, 2027

Study Description

PRIMARY OBJECTIVES:

Evaluate fluorine F 18 fluorthanatrace ([18F]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly [ADP-ribose] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor.

SECONDARY OBJECTIVES:

Evaluate the safety of [18F]Fluorthanatrace.
Correlate [18F]Fluorthanatrace uptake measures with BRCA mutation status.
Correlate [18F]Fluorthanatrace uptake measures with poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies.
Evaluate change in [18F]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation.
To confirm the variability of imaging findings from repeated [18F]FTT PET/CT over 1 week before treatment initiation
Determine the change in [18F]FluorThanatrace uptake before treatment initiation and at time of clinical progression
Correlate [18F]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status

OUTLINE:

Patients receive fluorodeoxyglucose (FDG) intravenously (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 fluorine F 18 fluorthanatrace ([18F]FTT) PET/CT over 1 hour.

After completion of study treatment, patients are followed up at 24 hours.

Connect with a study center

M D Anderson Cancer Center
Houston, Texas 77030
United States
Site Not Available
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United States
Active - Recruiting

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