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

Brief Title

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

Official Title

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

Brief 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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. 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:

      I. Evaluate the safety of [18F]Fluorthanatrace. II. Correlate [18F]Fluorthanatrace uptake
      measures with BRCA mutation status. III. Correlate [18F]Fluorthanatrace uptake measures with
      poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who
      undergo biopsies.

      IV. 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Incidence of adverse events

Condition

Breast Carcinoma

Intervention

Computed Tomography

Study Arms / Comparison Groups

 Treatment (FDG PET/CT, [18F]FTT PET/CT)

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

December 18, 2018

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lilie L Lin, 713-563-2300, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03604315

Organization ID

2017-0319

Secondary IDs

NCI-2018-01137

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Lilie L Lin, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

November 2019