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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 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.

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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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Fluoroglutamine [18F]F-GLN

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-04-05
Est. Completion 2026-12
Phase Phase 1

Sponsor

Abramson Cancer Center at Penn Medicine

402 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03863457

The ClinicalTrials.gov registry entry for NCT03863457 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.