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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    120
  • sponsor
    M.D. Anderson Cancer Center
Updated on 7 October 2022
ct scan
cancer
MRI
tumor cells
solid tumour
solid tumor
fallopian tube
peritoneal cancer
primary peritoneal carcinoma
fluorine f 18 fluorthanatrace

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.

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.
    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.

Details
Condition Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Solid Neoplasm
Treatment computed tomography, positron emission tomography, Fludeoxyglucose F-18, Fluorine F 18 Fluorthanatrace
Clinical Study IdentifierNCT03604315
SponsorM.D. Anderson Cancer Center
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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