Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03083288
• Other study ID #: UPCC 26116
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 22, 2017
• Est. completion date: February 22, 2025

Study information

• Verified date: August 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging) will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and treatment response, in subjects undergoing neoadjuvant therapy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 22, 2025
• Est. primary completion date: February 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants will be = 18 years of age

• Known or suspected (BIRADS 5 on imaging) primary breast cancer

• At least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included.

• Willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy

• Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

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 at screening.

• 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 Cancer
• Breast Neoplasms

Intervention

Drug:
• [18F]FluorThanatrace
[18F]FluorThanatrace is a radiotracer for PET/CT

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		2 years