Breast CancerFTT 2NCT03846167
Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace PET/CT
An observational study of Breast Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Patients with known or suspected, in the opinion of an investigator, primary or metastatic breast cancer may be eligible for this study. Up to 45 evaluable participants may undergo study imaging in this protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Imaging Drug FluorThanatrace (FTT)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who come to the clinical practices of the University of Pennsylvania for diagnosis and/or treatment of a known or suspected breast cancer and who meet the study inclusion criteria may be approached by study staff for recruitment into this study.
Who may be able to join
- Participants will be ≥ 18 years of age
- Known or suspected, in the opinion of an investigator, primary breast or metastatic breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard imaging.
- 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.
Who cannot join
- Females who are pregnant or breast feeding at the time of enrollment will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace Positron Emission Tomography (PET/CT)
Patients with known or suspected, in the opinion of an investigator, primary or metastatic breast cancer may be eligible for this study. Up to 45 evaluable participants may undergo study imaging in this protocol. The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of [18F]FTT. The planned scanning protocol will be selected by an investigator and will be discussed with the participant prior to the imaging visit. The PET/CT scan will include an injection of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in breast cancer and compare with PARP-1 activity in tissue, when available. If participants are getting neoadjuvant or other systemic therapy, a second optional scan may be performed 1 day to 4 weeks after therapy begins to evaluate whether response correlates with increase in PARP-1 activity.
Read the detailed description
Patients who come to the clinical practices of the University of Pennsylvania for diagnosis and/or treatment of a known or suspected breast cancer and who meet the study inclusion criteria may be approached by study staff for recruitment into this study. Eligibility criteria will be checked and study personnel will provide a copy of the approved consent form to the potential subject. Patients will be approached initially in person, by phone or email about study participation. The patient will be given an opportunity to go over the consent form and have any questions answered by study staff or a study investigator. After discussion of the study procedures, risks and benefits, if the patient agrees to participate in the study, the [18F]FTT PET/CT will be ordered by a physician and scheduled. Patients may cancel the scan appointment at any time prior to the injection of [18F]FTT with no negative impact to them or their medical care at UPenn. A written informed consent will be reviewed with the patient and signed prior to any study procedures being performed. Participants may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or administrative reasons. If a participant does not return for a scheduled visit, every effort will be made to contact the subject.
Women of childbearing potential will have a urine pregnancy test performed within 1 day prior to injection of [18F]FTT.
The baseline [18F]FTT PET/CT will take place prior to surgical resection of a primary breast cancer, or before starting therapy. Adverse event follow up after the PET/CT scan may occur by telephone or in person, depending on the participant's schedule. Follow up will take place the next available business day (i.e. not a weekend or a holiday). The adverse event monitoring period is 24 hours following [18F]FTT injection.
An optional post-therapy [18F]FTT PET/CT may occur approximately 1 day to 4 weeks after the start of new therapy regimen.
Participants will be asked to give consent to allow for collection of pathology tissue for use in this research study. Archival tissue may be collected from an existing tissue sample. Additional tissue may be collected during a clinical biopsy or surgical procedure, if a procedure is scheduled as part of their clinical care or, it can be collected for research purposes only, if the patient has consented for this additional collection.
Participants will be asked permission to access their medical records for follow up of their clinical care and treatment as part of the consent for this study.
Long term follow up will occur by medical record review for the duration of the participant's cancer care until death or 15 years after enrollment.
- Conditions
- Breast Cancer
- Being tested
- Imaging Drug FluorThanatrace (FTT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging Drug FluorThanatrace (FTT)Drug
[18F]FTT is an investigational radioactive PET drug used to see PARP-1 activity in tumors. This radioactive imaging drug is injected into the body to see how it goes into places where there is active breast cancer. Using an imaging scan called Positron Emission Tomography (PET/CT), the radioactive drug can be seen in the body.
| Study group | Role | What they receive |
|---|---|---|
| FTT PET/CT | The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of [18F]FTT.
Participants will be asked to complete the following research procedures: [18F]FTT PET/CT scan before surgery or treatment [18F]FTT PET/CT scan after you start treatment (optional) Receives: Drug: Imaging Drug FluorThanatrace (FTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PARP-1 Activity in Breast Cancer
Evaluate PARP-1 activity in breast cancer using measures of uptake of [18F]FluorThanatrace.
Measured: 4 Years
Secondary outcomes (3)
Activity in Tissues
Correlate [18F]FluorThanatrace uptake measures with PARP-1 pathology assays of activity in tissue.
Measured: 4 Years
Hormone Receptor Status
Correlate [18F]FluorThanatrace uptake measures with hormone receptor status.
Measured: 4 Years
Change After Therapy
Determine whether [18F]FluorThanatrace uptake measures change after therapy start.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start11 Feb 2019
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846167
- Sponsor's protocol ID
- 832165
- Acronym
- FTT 2
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2019
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33884961
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace Positron Emission Tomography (PET/CT)
- ClinicalTrials.gov ID
- NCT03846167
- Acronym / sponsor ID
- FTT 2 / 832165
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with known or suspected, in the opinion of an investigator, primary or metastatic breast cancer may be eligible for this study. Up to 45 evaluable participants may undergo study imaging in this protocol. The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of [18F]FTT. The planned scanning protocol will be selected by an investigator and will be discussed with the participant prior to the imaging visit. The PET/CT scan will include an injection of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in breast cancer and compare with PARP-1 activity in tissue, when available. If participants are getting neoadjuvant or other systemic therapy, a second optional scan may be performed 1 day to 4 weeks after therapy begins to evaluate whether response correlates with increase in PARP-1 activity.
Detailed description
Patients who come to the clinical practices of the University of Pennsylvania for diagnosis and/or treatment of a known or suspected breast cancer and who meet the study inclusion criteria may be approached by study staff for recruitment into this study. Eligibility criteria will be checked and study personnel will provide a copy of the approved consent form to the potential subject. Patients will be approached initially in person, by phone or email about study participation. The patient will be given an opportunity to go over the consent form and have any questions answered by study staff or a study investigator. After discussion of the study procedures, risks and benefits, if the patient agrees to participate in the study, the [18F]FTT PET/CT will be ordered by a physician and scheduled. Patients may cancel the scan appointment at any time prior to the injection of [18F]FTT with no negative impact to them or their medical care at UPenn. A written informed consent will be reviewed with the patient and signed prior to any study procedures being performed. Participants may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or administrative reasons. If a participant does not return for a scheduled visit, every effort will be made to contact the subject.
Women of childbearing potential will have a urine pregnancy test performed within 1 day prior to injection of [18F]FTT.
The baseline [18F]FTT PET/CT will take place prior to surgical resection of a primary breast cancer, or before starting therapy. Adverse event follow up after the PET/CT scan may occur by telephone or in person, depending on the participant's schedule. Follow up will take place the next available business day (i.e. not a weekend or a holiday). The adverse event monitoring period is 24 hours following [18F]FTT injection.
An optional post-therapy [18F]FTT PET/CT may occur approximately 1 day to 4 weeks after the start of new therapy regimen.
Participants will be asked to give consent to allow for collection of pathology tissue for use in this research study. Archival tissue may be collected from an existing tissue sample. Additional tissue may be collected during a clinical biopsy or surgical procedure, if a procedure is scheduled as part of their clinical care or, it can be collected for research purposes only, if the patient has consented for this additional collection.
Participants will be asked permission to access their medical records for follow up of their clinical care and treatment as part of the consent for this study.
Long term follow up will occur by medical record review for the duration of the participant's cancer care until death or 15 years after enrollment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FTT PET/CT | – | Drug: Imaging Drug FluorThanatrace (FTT)The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of [18F]FTT. Participants will be asked to complete the following research procedures: [18F]FTT PET/CT scan before surgery or treatment [18F]FTT PET/CT scan after you start treatment (optional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who come to the clinical practices of the University of Pennsylvania for diagnosis and/or treatment of a known or suspected breast cancer and who meet the study inclusion criteria may be approached by study staff for recruitment into this study.
Key inclusion criteria (3 listed)
- Participants will be ≥ 18 years of age
- Known or suspected, in the opinion of an investigator, primary breast or metastatic breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard imaging.
- 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.
Key exclusion criteria (3 listed)
- Females who are pregnant or breast feeding at the time of enrollment will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging Drug FluorThanatrace (FTT)[18F]FTT is an investigational radioactive PET drug used to see PARP-1 activity in tumors. This radioactive imaging drug is injected into the body to see how it goes into places where there is active breast cancer. Using an imaging scan called Positron Emission Tomography (PET/CT), the radioactive drug can be seen in the body. | Drug | FTT PET/CT |
Primary outcome
PARP-1 Activity in Breast Cancer
Time frame: 4 Years
Evaluate PARP-1 activity in breast cancer using measures of uptake of [18F]FluorThanatrace.
3 secondary outcomes
Activity in Tissues
Time frame: 4 Years
Hormone Receptor Status
Time frame: 4 Years
Change After Therapy
Time frame: 4 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Derived from this study: PubMed 33884961McDonald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PARP-1 Activity in Breast Cancer (time frame: 4 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.