NCT03083288

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

Active, enrolled Phase 1 Last updated 10 September 2025

What this trial tests

Phase 1 trial testing [18F]FluorThanatrace in Breast Cancer in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 February 2017

Primary endpoint
22 February 2026

22 February 2026

Quick facts

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	22 February 2017
Primary completion	22 February 2026
Estimated completion	22 February 2026
Sites	1 location across United States

Drugs / interventions tested

• [18F]FluorThanatrace — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Positron Emission Tomography Imaging of Poly-(Adenosine Diphosphate-Ribose) Polymerase 1 Expression in Breast Cancer: A Nonrandomized Clinical Trial.
   McDonald ES, Doot RK, Pantel AR, Farwell MD, et al · · 2020 · cited 32× · PMID 32297911 · DOI 10.1001/jamaoncol.2020.0334
2. Advancements in PARP1 Targeted Nuclear Imaging and Theranostic Probes.
   Ambur Sankaranarayanan R, Kossatz S, Weber W, Beheshti M, et al · · 2020 · cited 30× · PMID 32640708 · DOI 10.3390/jcm9072130
3. In vivo visualization of PARP inhibitor pharmacodynamics.
   McDonald ES, Pantel AR, Shah PD, Farwell MD, et al · · 2021 · cited 25× · PMID 33884961 · DOI 10.1172/jci.insight.146592
4. Application of PET Tracers in Molecular Imaging for Breast Cancer.
   Boers J, de Vries EFJ, Glaudemans AWJM, Hospers GAP, et al · · 2020 · cited 25× · PMID 32627087 · DOI 10.1007/s11912-020-00940-9
5. Development of Radiotracers for Breast Cancer-The Tumor Microenvironment as an Emerging Target.
   Heesch A, Maurer J, Stickeler E, Beheshti M, et al · · 2020 · cited 15× · PMID 33096754 · DOI 10.3390/cells9102334
6. Direct Imaging of Drug Distribution and Target Engagement of the PARP Inhibitor Rucaparib.
   Kossatz S, Carney B, Farley C, Weber WA, et al · · 2018 · cited 12× · PMID 29572258 · DOI 10.2967/jnumed.117.205765
7. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
8. DNA Repair Enzyme Poly(ADP-Ribose) Polymerase 1/2 (PARP1/2)-Targeted Nuclear Imaging and Radiotherapy.
   Nguyen NT, Pacelli A, Nader M, Kossatz S. · · 2022 · cited 9× · PMID 35267438 · DOI 10.3390/cancers14051129