Clinical trial NCT03083288: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
Official title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Elizabeth McDonald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonald ES, Pantel AR, Shah PD, Farwell MD, Clark AS, Doot RK, Pryma DA, Carlin SD. In vivo visualization of PARP inhibitor pharmacodynamics. JCI Insight. 2021 Apr 22;6(8):e146592. doi: 10.1172/jci.insight.146592.