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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03604315
• Other study ID #: 2017-0319
• Secondary ID: NCI-2018-0113720
• Status: Recruiting
• Phase: Phase 1
• Start date: December 18, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lilie Lin
• Phone: 713-563-2300
• Email: lllin[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Recurrence
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Solid Neoplasm

Intervention

Procedure:
• Computed Tomography
Undergo FDG PET/CT
• Computed Tomography
Undergo [18F]FTT PET/CT

Radiation:
• Fludeoxyglucose F-18
Given IV
• Fluorine F 18 Fluorthanatrace
Given IV

Procedure:
• Positron Emission Tomography
Undergo FDG PET/CT
• Positron Emission Tomography
Undergo [18F]FTT PET/CT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 years
Secondary	Incidence of adverse events		Up to 4 years
Secondary	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.	Up to 4 years
Secondary	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.	Up to 4 years
Secondary	Change in fluorine F 18 fluorthanatrace uptake measures after therapy		Baseline up to 4 years

External Links

•   MD Anderson Cancer Center