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PET/CT with Tracers for Breast Cancer

Phase 1
Waitlist Available
Led By David M Schuster, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment naive biopsy proven ILC patients with ILC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well two radiotracers, fluciclovine and PSMA, work in helping doctors understand and classify invasive lobular breast cancer.

Who is the study for?
This trial is for patients with invasive lobular breast cancer that may have spread, who haven't started treatment yet. They should be open to biopsies if needed. Pregnant women or those able to conceive without being postmenopausal for at least a year (if over 55) can't join.Check my eligibility
What is being tested?
The study tests how well two PET/CT imaging scans using fluciclovine and PSMA radiotracers work in classifying and staging invasive lobular breast cancer that might have metastasized.See study design
What are the potential side effects?
Since this trial involves diagnostic imaging rather than drug treatments, side effects are minimal but may include discomfort from the procedure or reactions to the tracers used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have invasive lobular carcinoma (ILC) and haven't received any treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Verified detection rate for invasive lobular breast cancer
Verified detection rate for metastasis
Other outcome measures
Imaging results
Presence or absence of metastasis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)Experimental Treatment4 Interventions
Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Urea
FDA approved
Fluciclovine (18F)
FDA approved

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,297 Total Patients Enrolled
3 Trials studying Breast Carcinoma
194 Patients Enrolled for Breast Carcinoma
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,510 Total Patients Enrolled
1 Trials studying Breast Carcinoma
140 Patients Enrolled for Breast Carcinoma
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,371 Total Patients Enrolled
100 Trials studying Breast Carcinoma
42,905 Patients Enrolled for Breast Carcinoma

Media Library

Fluciclovine F18 Clinical Trial Eligibility Overview. Trial Name: NCT04750473 — Phase 1
Breast Carcinoma Research Study Groups: Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)
Breast Carcinoma Clinical Trial 2023: Fluciclovine F18 Highlights & Side Effects. Trial Name: NCT04750473 — Phase 1
Fluciclovine F18 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750473 — Phase 1

Frequently Asked Questions

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

What possible adverse effects might patients experience from Fluciclovine F18?

"Due to the limited clinical data, our team at Power gives Fluciclovine F18 a score of 1 in terms of safety. This is because it is currently undergoing Phase 1 trials and there has not been adequate testing proving its efficacy or safety."

Answered by AI

In what medical context is Fluciclovine F18 commonly prescribed?

"Fluciclovine F18 is widely employed to treat prostate cancer, as well as a range of other issues such as eczema, dyshidrotic and psoriasis symptoms, and neurodermatitis."

Answered by AI

What is the scope of participant inclusion in this clinical trial?

"Indeed, the data on clinicaltrials.gov suggests that this research study is in progress and recruiting participants. This endeavor was first announced on July 16th 2021 and has been most recently amended on August 9th 2022. The trial requires 20 patients to be admitted from a single medical centre."

Answered by AI

Is this research initiative currently seeking participants?

"According to the data posted on clinicaltrials.gov, this medical study is currently recruiting participants; it was first made available for enrolment in July 2021 and its information has been updated most recently in August 2022."

Answered by AI

Are there any reports of past experiments featuring Fluciclovine F18?

"Currently, 26 clinical studies centred around Fluciclovine F18 are underway. Of those trials, 4 have reached the final phase of testing before approval. 51 sites across Iowa City are conducting these tests."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
David M Schuster 2021. "Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04750473.
~4 spots leftby Dec 2024
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