Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computed Tomography, Computed Tomography, Fludeoxyglucose F-18, Fluorine F 18 Fluorthanatrace.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
Overview
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:
\- 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.
Interventions
- Procedure Computed Tomography
Undergo FDG PET/CT - Procedure Computed Tomography
Undergo \[18F\]FTT PET/CT - Radiation Fludeoxyglucose F-18
Given IV - Radiation Fluorine F 18 Fluorthanatrace
Given IV - Procedure Positron Emission Tomography
Undergo FDG PET/CT - Procedure Positron Emission Tomography
Undergo \[18F\]FTT PET/CT
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Incidence of adverse events [Time frame: Up to 4 years]
- BRCA mutation status [Time frame: Up to 4 years]
- PARP-1 activity in tumor tissue samples [Time frame: Up to 4 years]
- Change in fluorine F 18 fluorthanatrace uptake measures after therapy [Time frame: Baseline up to 4 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Publications
- Lin LL, Wong F, Lin R, Yap T, Litton JK. Pharmacodynamic Activity of [18F]-Fluorthanatrace Poly(ADP-ribose) Polymerase Positron Emission Tomography in Patients With BRCA1/2-Mutated Breast Cancer Receiving Talazoparib. JCO Precis Oncol. 2024 Aug;8:e2400303. doi: 10.1200/PO.24.00303. PMID 39208372
Identifiers
NCT: NCT03604315 · 2017-0319 · NCI-2018-01137 · 2017-0319 · R01CA249329