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

March 14, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lilie L. Lin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (FDG PET/CT, [18F]FTT PET/CT)
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.
Undergo FDG PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Undergo FDG PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Given IV
Other Names:
  • [18F]FluorThanatrace
  • [18F]FTT
Given IV
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Undergo [18F]FTT PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Undergo [18F]FTT PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
Time Frame: Up 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.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 4 years
Up to 4 years
BRCA mutation status
Time Frame: Up 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.
Up to 4 years
PARP-1 activity in tumor tissue samples
Time Frame: Up 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.
Up to 4 years
Change in fluorine F 18 fluorthanatrace uptake measures after therapy
Time Frame: Baseline up to 4 years
Baseline up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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