Cytoreductive SurgeryNCT05390021
PET/MRI in Endometrial Cancer
A study testing PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent in people with Cytoreductive Surgery and Grade 3 Endometrial Endometrioid Adenocarcinoma, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cytoreductive Surgery, Grade 3 Endometrial Endometrioid Adenocarcinoma, High Grade Serous Carcinoma
- What is being tested?
- PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
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- 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
About this study
Official title: Diagnostic Performance of PET/MRI Versus Standard of Care Imaging (PET/CT and/or CT and/or PET) in Preoperative Women With Presumed Early-stage High Grade Endometrial Carcinoma
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)
Read the 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.
- Conditions
- Cytoreductive Surgery, Grade 3 Endometrial Endometrioid Adenocarcinoma, High Grade Serous Carcinoma, Endometrial Undifferentiated Carcinoma, Endometrial Mixed Cell Adenocarcinoma
- Being tested
- PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agentCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| PET/MRI IN ENDOMETRIAL CANCER | Experimental | PET/MRI in one study visit of approximately four hours Receives: Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start30 Mar 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Why it stopped: Unable to enroll patients to study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytoreductive SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onofrio A. Catalano, MD, PhD, Massachusetts General Hospital
- Investigators
- Onofrio Catalono, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390021
- Sponsor's protocol ID
- 22-112
- Status last verified
- Apr 2024
- First submitted
- 18 May 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of PET/MRI Versus Standard of Care Imaging (PET/CT and/or CT and/or PET) in Preoperative Women With Presumed Early-stage High Grade Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT05390021
- Acronym / sponsor ID
- 22-112
- Conditions
- Cytoreductive Surgery, Grade 3 Endometrial Endometrioid Adenocarcinoma, High Grade Serous Carcinoma, Endometrial Undifferentiated Carcinoma, Endometrial Mixed Cell Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients to study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MRI IN ENDOMETRIAL CANCER | Experimental | Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agentPET/MRI in one study visit of approximately four hours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agentThe research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours. | Combination product | PET/MRI IN ENDOMETRIAL CANCER |
Primary outcome
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion
Time frame: Baseline
Sensitivity of PET/MRI to detect metastatic lesions
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology
Time frame: Baseline
Specificity of PET/MRI to detect abscence of metastatic lesions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onofrio Catalono, MD, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent in people with Cytoreductive Surgery and Grade 3 Endometrial Endometrioid Adenocarcinoma, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.