What is the mechanism of action of this treatment?

Endometriosis treatments often target hormonal pathways to reduce estrogen levels or block its effects, as estrogen promotes the growth of endometrial tissue. Common treatments include estrogen-progestin contraceptives, which suppress ovulation and reduce menstrual flow, and GnRH agonists/antagonists, which lower estrogen production by downregulating the pituitary gland. Dienogest, a progestin, reduces endometrioma volume and pain by creating a hypoestrogenic environment. These treatments are crucial for managing symptoms and preventing disease progression. The F-18 FES PET/MRI trial leverages the binding of a radiotracer to estrogen receptors, enhancing imaging of endometriotic lesions, which underscores the importance of understanding estrogen's role in endometriosis.

What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies such as estrogen-progestin contraceptives, GnRH agonists, and progestins like dienogest. Estrogen-progestin contraceptives can cause side effects like nausea, weight gain, and mood changes. GnRH agonists may lead to menopausal symptoms such as hot flashes, decreased bone density, and mood swings. Progestins like dienogest are associated with weight gain, breast tenderness, and mood changes. These treatments interact with estrogen receptors, similar to the mechanism studied in F-18 FES PET/MRI imaging.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies. These include GnRH agonists, which reduce estrogen production, and aromatase inhibitors, which block estrogen synthesis. While the F-18 FES PET/MRI trial is investigating a radiotracer that binds to estrogen receptors for enhanced imaging, similar estrogen receptor-targeting treatments for endometriosis are not explicitly mentioned in the context. However, the use of hormone therapies that modulate estrogen levels is a common approach in managing endometriosis symptoms.

What other types of research exist?

A promising novel alternative to F-18 FES PET/MRI for endometriosis patients is the use of 4-fluoro-11β-methoxy-16α-[(18)F]fluoroestradiol (4FMFES). This radiotracer has demonstrated higher uptake in ER+ tissues and better tumor-to-background ratios compared to FES, potentially offering improved imaging for ER-expressing lesions.

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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

Must not have

Postmenopausal women

Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the detection of endometriosis using a special imaging technique. This method uses a substance that lights up endometriosis tissue on scans, helping doctors diagnose the condition more accurately.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a woman who has gone through menopause.

Select...

I cannot have IV Gadolinium contrast due to kidney issues or an allergy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection of Endometriosis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: F-18 FES PET/MRIExperimental Treatment1 Intervention

16α-(18)F-fluoro-17β-estradiol (\[F-18\] FES)

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endometriosis treatments often target hormonal pathways to reduce estrogen levels or block its effects, as estrogen promotes the growth of endometrial tissue. Common treatments include estrogen-progestin contraceptives, which suppress ovulation and reduce menstrual flow, and GnRH agonists/antagonists, which lower estrogen production by downregulating the pituitary gland. Dienogest, a progestin, reduces endometrioma volume and pain by creating a hypoestrogenic environment. These treatments are crucial for managing symptoms and preventing disease progression. The F-18 FES PET/MRI trial leverages the binding of a radiotracer to estrogen receptors, enhancing imaging of endometriotic lesions, which underscores the importance of understanding estrogen's role in endometriosis.

State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.Pre and post operative medical therapy for endometriosis surgery.