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NCT05659797 · ClinicalTrials.gov registry record · Early Phase 1
FES BPET-DBT in Newly Diagnosed Breast Cancer
A Early Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05659797: Recruiting Early Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
NCT05659797 is a Early Phase 1 study of Breast Cancer that is actively recruiting participants, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05659797, a Early Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Abramson Cancer Center at Penn Medicine.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of \[18F\]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.
Primary Outcome
Different types of SUV measurements (e.g. Max, Mean and Peak) may be tested to identify the optimal method for analyses for future studies of FES-BPET/DBT.
Conditions Studied
Interventions
- DEVICE BPET/DBT imaging
- DRUG 18F-FES
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2028-01 |
| Phase | Early Phase 1 |
What NCT05659797 shows while recruiting
NCT05659797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which BPET/DBT imaging is the first listed.
NCT05659797 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05659797 about?
NCT05659797 is a clinical study titled "FES BPET-DBT in Newly Diagnosed Breast Cancer". Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will pa...
What is the current status of trial NCT05659797?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-02. Estimated completion is 2028-01.
What conditions does trial NCT05659797 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05659797?
The interventions under investigation include: BPET/DBT imaging (DEVICE), 18F-FES (DRUG).
Who is sponsoring clinical trial NCT05659797?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05659797 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05659797's enrollment target sits among peer trials
20 1079th of 1224 higher than 112 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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