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NCT03863457 · ClinicalTrials.gov registry record · Phase 1
[18F] F-GLN by PET/CT in Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03863457: Recruiting Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
NCT03863457 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 40 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
NCT03863457, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Abramson Cancer Center at Penn Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with known or suspected primary or metastatic breast cancer with one 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 40 evaluable subjects will participate in a single imaging cohort. Patients will be stratified for analysis by breast cancer subtype with prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC). Participants may be treatment naïve or have received up to 3 weeks of treatment at the time of the \[18F\]F-Gln PET/CT scan. This is an observational study; \[18F\]F-GLN PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]F-GLN PET/CT results, treatment decisions are made by the treating physicians based upon clinical criteria. \[18F\]F-GLN PET/CT imaging sessions will include an injection of \[18F\]F-GLN. Metabolism data will be collected. Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of \[18F\]F-GLN in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of \[18F\]F-GLN will also be evaluated in all subjects.
Primary Outcome
Evaluate the biodistribution of \[18F\]F-GLN by measuring organ and whole body dosimetry.
Conditions Studied
Interventions
- DRUG Fluoroglutamine [18F]F-GLN
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT03863457 shows while recruiting
NCT03863457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 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 1 intervention - of which Fluoroglutamine [18F]F-GLN is the first listed.
NCT03863457 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03863457 about?
NCT03863457 is a clinical study titled "[18F] F-GLN by PET/CT in Breast Cancer". Patients with known or suspected primary or metastatic breast cancer with one 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 40 evaluable subjects will participate in a single imaging coh...
What is the current status of trial NCT03863457?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-04-05. Estimated completion is 2026-12.
What conditions does trial NCT03863457 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03863457?
The interventions under investigation include: Fluoroglutamine [18F]F-GLN (DRUG).
Who is sponsoring clinical trial NCT03863457?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03863457 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 NCT03863457's enrollment target sits among peer trials
40 876th of 1224 higher than 325 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.
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