PET/MRI in Endometrial Cancer | NCT05390021

Studies
PET/MRI in Endometrial Cancer

NCT05390021

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Apr 2, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cytoreductive Surgery
Grade 3 Endometrial Endometrioid Adenocarcinoma
High Grade Serous Carcinoma
Endometrial Undifferentiated Carcinoma
Endometrial Mixed Cell Adenocarcinoma

Interventions

PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent

Countries

Not provided

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Withdrawn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

Unable to enroll patients to study

Expanded Access Info

Start Date

Mar 30, 2024Estimated

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2026Estimated

First Submitted Date

May 18, 2022

First Submission Date that Met QC Criteria

May 21, 2022

First Posted Date

May 25, 2022Actual

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

Apr 1, 2024

Last Update Posted Date

Apr 2, 2024Actual

Description Module

Brief Summary

This study is investigating if positron emission tomography (PET)/Magnetic resonance imaging (MRI) is more effective than the currently used imaging modalities (computed tomography [CT], or PET/CT) for high-risk endometrial cancer.

The name of the intervention involved in this study is:

Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)

Detailed Description

This research study involves undergoing a diagnostic imaging procedure called positron emission tomography/magnetic resonance imaging (PET/MRI). This type of scan uses a powerful magnet and a special drug that emits a small but detectable amount of radiation to show detailed images of tumors. This study, will examine the diagnostic effectiveness of positron emission tomography/magnetic resonance imaging (PET/MRI), which will be the intervention. The study will compare the results of this scan to either the computed tomography (CT) or PET/CT that participants would normally undergo as a standard of care for high-risk endometrial cancer.

The research study procedures include a screening for eligibility and a single study visit.

Participants will undergo the PET/MRI in one study visit of approximately four hours.
It is expected that about thirty-three (33) people will take part in this research study.

The U.S. Food and Drug Administration (FDA) has approved the PET/MRI scanner as a diagnostic modality option for indications that include for high-risk endometrial cancer.

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

Not Applicable

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
PET/MRI IN ENDOMETRIAL CANCER	Experimental	PET/MRI in one study visit of approximately four hours	Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent	Combination Product	The research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion	Sensitivity of PET/MRI to detect metastatic lesions	Baseline
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology	Specificity of PET/MRI to detect abscence of metastatic lesions	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18-85 years old with an endometrial biopsy-confirmed diagnosis of either grade 3 endometrioid, serous, carcinosarcoma, undifferentiated or mixed cell carcinoma
Must have presumed stage I disease, i.e., no symptoms suggesting disease outside of the uterus (weight loss, early satiety, bloating, changes in bowel movement, etc.)
Planning to undergo cytoreductive surgery with a Gynecologic oncologist employed by Massachusetts General Hospital
No previous history of chronic severe renal insufficiency and a glomerular filtration rate of >30 mL/min/1.73m2. If the patient has a history of acute renal failure but their GFR as recovered to above 30,

Exclusion Criteria:

Weight greater than 300lbs (the PET/MRI table weight limit) or BMI > 33
Subjects less than 18 years of age or greater than 85 years of age
Has Electrical implants, such as cardiac pacemakers or perfusion pumps
Has Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants not compatible with a 3 Tesla MR.
Is actively anticipating being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate)
Suffers from claustrophobia
If research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months)
Is unable to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis)
Subject is under the direct professional supervision of the principal investigator
A history of chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
Perioperative liver transplantation period

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Onofrio Catalono, MD, PhD	Massachusetts General Hospital	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Data can be shared no earlier than 1 year following the date of publication

Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

URL

Not provided

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates