Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
Primary Purpose
Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Computed Tomography
Fludeoxyglucose F-18
Fluorine F 18 Fluorthanatrace
Positron Emission Tomography
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional treatment trial for Breast Carcinoma
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.
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Arm 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.
Outcomes
Primary Outcome Measures
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
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.
Secondary Outcome Measures
Incidence of adverse events
BRCA mutation status
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.
PARP-1 activity in tumor tissue samples
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.
Change in fluorine F 18 fluorthanatrace uptake measures after therapy
Full Information
NCT ID
NCT03604315
First Posted
July 19, 2018
Last Updated
August 29, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03604315
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
- 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Solid Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo FDG PET/CT
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo [18F]FTT PET/CT
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Fluorine F 18 Fluorthanatrace
Other Intervention Name(s)
[18F]FluorThanatrace, [18F]FTT
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo FDG PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo [18F]FTT PET/CT
Primary Outcome Measure Information:
Title
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
Description
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.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Up to 4 years
Title
BRCA mutation status
Description
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.
Time Frame
Up to 4 years
Title
PARP-1 activity in tumor tissue samples
Description
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.
Time Frame
Up to 4 years
Title
Change in fluorine F 18 fluorthanatrace uptake measures after therapy
Time Frame
Baseline up to 4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lilie Lin
Phone
713-563-2300
Email
lllin@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilie L Lin
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilie L. Lin, MD
Phone
713-563-2300
Email
lllin@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lilie L. Lin, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
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