Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estrad... | NCT04347135

Studies
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI

NCT04347135

Sponsor

Annie (Annie) T. Packard

Status

Withdrawn

Last Update Posted

May 10, 2024Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Endometriosis

Interventions

F-18 FES

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No Enrollment

Expanded Access Info

Start Date

Oct 7, 2022Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Apr 30, 2024Actual

First Submitted Date

Apr 13, 2020

First Submission Date that Met QC Criteria

Apr 13, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2024

Last Update Posted Date

May 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F-18 FES PET/MRI	Experimental	16α-(18)F-fluoro-17β-estradiol ([F-18] FES)	Drug: F-18 FES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
F-18 FES	Drug	F-18 FES PET/MRI for detection of endometriosis.	F-18 FES PET/MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of Endometriosis	Comparisons will be made descriptively between conventional MRI imaging, FES PET/MRI imaging and surgical/pathologic findings. Outcome data include number of detected lesions, differences in the accuracy for detection of active disease versus inactive fibrosis, and confidence score.	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Premenopausal women (18-50) with endometriosis

Exclusion Criteria:

Postmenopausal women
AP diameter when lying supine greater than 32 cm (too large for PET/MRI)
Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)
Pregnant (Urine test will be provided for all patients)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann Packard, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided