Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerPhase 1NCT02637934
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
A Phase 1 study testing [18F]FluorThanatrace and PET/CT imaging sessions in people with Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- What is being tested?
- [18F]FluorThanatrace and PET/CT imaging sessions
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2016to Aug 2028
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be ≥ 18 years of age
- History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
- At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and compare with PARP-1 activity in tissue.
Read the detailed description
Primary Objectives
- Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of [18F]FluorThanatrace
Secondary Objectives
- Evaluate the safety of [18F]FluorThanatrace
- Correlate [18F]FluorThanatrace uptake measures with BRCA mutation status
- Correlate [18F]FluorThanatrace uptake measures with PARP-1 activity in tumor.
- Determine biodistribution of the radioactive investigational drug ([18F]FluorThanatrace) in patients and calculate human dosimetry.
- Evaluate change in [18F]FluorThanatrace uptake measures after therapy
- Being tested
- [18F]FluorThanatrace, PET/CT imaging sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FluorThanatraceDrug
PET/CT imaging sessionsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Biodistribution | Experimental | The Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over a period of approximately 4 hours.
Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects. Receives: Drug: [18F]FluorThanatrace; Radiation: PET/CT imaging sessions |
| Dynamic | Experimental | The Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of [18F]FTT. Receives: Drug: [18F]FluorThanatrace; Radiation: PET/CT imaging sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start14 Jan 2016
- Primary completion28 Aug 2026
- Study completionAug 2028 (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 Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona Simpkins, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637934
- Sponsor's protocol ID
- UPCC 18815
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2015
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Makvandi M, Pantel A, Schwartz L, Schubert E, Xu K, Hsieh CJ, Hou C, Kim H, Weng CC, Winters H, Doot R, Farwell MD, Pryma DA, Greenberg RA, Mankoff DA, Simpkins F, Mach RH, Lin LL. A PET imaging agent for evaluating PARP-1 expression in ovarian cancer. J Clin Invest. 2018 May 1;128(5):2116-2126. doi: 10.1172/JCI97992. Epub 2018 Apr 16.
PubMed 29509546
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
- ClinicalTrials.gov ID
- NCT02637934
- Acronym / sponsor ID
- UPCC 18815
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- 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.
Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and compare with PARP-1 activity in tissue.
Detailed description
Primary Objectives
- Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of [18F]FluorThanatrace
Secondary Objectives
- Evaluate the safety of [18F]FluorThanatrace
- Correlate [18F]FluorThanatrace uptake measures with BRCA mutation status
- Correlate [18F]FluorThanatrace uptake measures with PARP-1 activity in tumor.
- Determine biodistribution of the radioactive investigational drug ([18F]FluorThanatrace) in patients and calculate human dosimetry.
- Evaluate change in [18F]FluorThanatrace uptake measures after therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodistribution | Experimental | Drug: [18F]FluorThanatrace, Radiation: PET/CT imaging sessionsThe Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over a period of approximately 4 hours. Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects. |
| Dynamic | Experimental | Drug: [18F]FluorThanatrace, Radiation: PET/CT imaging sessionsThe Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of [18F]FTT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be ≥ 18 years of age
- History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
- At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| [18F]FluorThanatrace | Drug | Biodistribution, Dynamic |
| PET/CT imaging sessions | Radiation | Biodistribution, Dynamic |
Primary outcome
Number of Adverse Events
Time frame: 3 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 2 Sep 2026.
- Derived from this study: PubMed 29509546Makvandi M, Pantel A, Schwartz L, Schubert E, Xu K, Hsieh CJ, Hou C, Kim H, Weng CC, Winters H, Doot R, Farwell MD, Pryma DA, Greenberg RA, Mankoff DA, Simpkins F, Mach RH, Lin LL. A PET imaging agent for evaluating PARP-1 expression in ovarian cancer. J Clin Invest. 2018 May 1;128(5):2116-2126. doi: 10.1172/JCI97992. Epub 2018 Apr 16.
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.
Fiona Simpkins, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]FluorThanatrace and PET/CT imaging sessions in people with Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine 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 2 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Adverse Events (time frame: 3 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 NCT02637934, 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 2 Sep 2026.