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FES-PET/DBT Imaging for Breast Cancer

Q: Are there any vacancies available for patients to join this clinical investigation?

<p>Clinicaltrials.gov has reported that this medical trial, first posted on January 1st 2023, is no longer recruiting patients as of December 12th 2022. However, there are still 2618 other studies actively enrolling participants at present.</p>

Phase < 1

Recruiting

Led By Christine Edmonds, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be ≥ 18 years of age.

Known ER positive (by immunohistochemistry) breast cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will assess if a novel imaging device combining PET & DBT can aid in the diagnosis of breast cancer for those 18+. Up to 20 evaluable subjects will take part and receive FES-BPET/DBT imaging, but results won't direct treatment decisions.

Who is the study for?

This trial is for adults over 18 with newly diagnosed estrogen-receptor positive breast cancer, featuring at least one lesion that's 1.0 cm or larger. It's not suitable for pregnant or breastfeeding women, those unable to undergo imaging procedures, taking tamoxifen/raloxifene, or with conditions compromising safety/participation.Check my eligibility

What is being tested?

The study tests a new imaging technique combining Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) after an [18F]-Fluoroestradiol (FES) injection in patients. This observational study won't influence treatment decisions; up to 20 subjects will be imaged once.See study design

What are the potential side effects?

Since this is an observational imaging study using BPET/DBT and FES injection, traditional medication side effects are not the focus. However, there may be risks associated with the imaging process itself or reactions to the FES tracer used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My breast cancer is estrogen receptor positive.

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I have a tumor larger than 1 cm visible on an imaging test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Image artifacts

Image quality

Parenchymal appearance

+2 more

Secondary outcome measures

Estrogen receptor IHC

Trial Design

1Treatment groups

Experimental Treatment

Group I: FES BPET-DBTExperimental Treatment2 Interventions

FES-BPET/DBT imaging session

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,624 Total Patients Enrolled

44 Trials studying Breast Cancer

60,829 Patients Enrolled for Breast Cancer

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,024 Total Patients Enrolled

41 Trials studying Breast Cancer

35,313 Patients Enrolled for Breast Cancer

Christine Edmonds, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

Media Library

FES BPET-DBT Clinical Trial Eligibility Overview. Trial Name: NCT05659797 — Phase < 1

Breast Cancer Research Study Groups: FES BPET-DBT

Breast Cancer Clinical Trial 2023: FES BPET-DBT Highlights & Side Effects. Trial Name: NCT05659797 — Phase < 1

FES BPET-DBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659797 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to join this clinical investigation?

"Clinicaltrials.gov has reported that this medical trial, first posted on January 1st 2023, is no longer recruiting patients as of December 12th 2022. However, there are still 2618 other studies actively enrolling participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FES BPET-DBT in Newly Diagnosed Breast Cancer

2023. "FES BPET-DBT in Newly Diagnosed Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659797.