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F-18 FES Imaging for Endometriosis

Phase 1 & 2
Waitlist Available
Led By Ann Packard, MD
Research Sponsored by Annie (Annie) T. Packard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal women (18-50) with endometriosis
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing whether using F-18 FES PET/MRI to look for endometriosis is better than using other methods.

Who is the study for?
This trial is for premenopausal women aged 18-50 who have been diagnosed with endometriosis. It's not suitable for postmenopausal women, those too large to fit in a PET/MRI machine, anyone unable to undergo PET/MRI (due to metal implants or severe claustrophobia), those who can't receive IV Gadolinium contrast (due to kidney issues or allergies), or pregnant women.Check my eligibility
What is being tested?
The study is testing the use of a special imaging technique called F-18 FES PET/MRI to see if it can better detect endometriosis in affected individuals compared to current methods.See study design
What are the potential side effects?
Potential side effects may include reactions related to the IV Gadolinium contrast used during imaging, such as nausea, pain at injection site, and allergic reactions. The F-18 FES tracer itself may cause similar side effects but these are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-50 with endometriosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of Endometriosis

Trial Design

1Treatment groups
Experimental Treatment
Group I: F-18 FES PET/MRIExperimental Treatment1 Intervention
16α-(18)F-fluoro-17β-estradiol ([F-18] FES)

Find a Location

Who is running the clinical trial?

Annie (Annie) T. PackardLead Sponsor
Ann Packard, MDPrincipal InvestigatorMayo Clinic

Media Library

F-18 FES Clinical Trial Eligibility Overview. Trial Name: NCT04347135 — Phase 1 & 2
Endometriosis Research Study Groups: F-18 FES PET/MRI
Endometriosis Clinical Trial 2023: F-18 FES Highlights & Side Effects. Trial Name: NCT04347135 — Phase 1 & 2
F-18 FES 2023 Treatment Timeline for Medical Study. Trial Name: NCT04347135 — Phase 1 & 2
Endometriosis Patient Testimony for trial: Trial Name: NCT04347135 — Phase 1 & 2

Frequently Asked Questions

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

How can I become involved in this research project?

"Endometrioma is a prerequisite for enrolment in this study. Additionally, all participants must be between 18-50 years old. Up to 10 patients can join the trial."

Answered by AI

What is the size of the test group for this research project?

"This specific study is no longer recruiting patients, with the last update to clinicaltrials.gov being on October 17th, 2022. However, there are 93 other studies actively looking for participants with endometrioma and 4 trials for F-18 FES that still need volunteers."

Answered by AI

Is F-18 FES a new area of research?

"Currently, there are 4 ongoing studies being conducted to research F-18FES. None of these trials have reached Phase 3 yet. Although the majority of these studies originate from Rochester, Minnesota, there are a total of 29 locations running investigations into this potential treatment."

Answered by AI

Does this trial have an age limit?

"The age limit for this clinical trial is 18-50 years old."

Answered by AI

Are new participants currently being enrolled in this clinical trial?

"According to the official website, this clinical trial is not currently looking for patients. The study was posted on October 7th, 2020 and updated on October 17th, 2020. 97 other trials are actively recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been working with doctors and medications since my endometriosis diagnosis in my early 20s. I have had 3 successful spontaneous pregnancies. I have tried so many things and want to help figure out better treatments/diagnosis for women, especially my 4 daughters if they inherit the predisposition to endometriosis. I am now 40 years old and the pain still catches me off guard as it's worsened since my last pregnancy at 32. All of the treatment options available have such detrimental side effects or feel very extreme.
PatientReceived 2+ prior treatments
~4 spots leftby Apr 2025