Endometrial CancerNCT02765698
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
An observational study of Endometrial Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Mar 2018
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with biopsy-proven high risk (type 2 or grade 3 endometrioid histology) endometrial cancer undergoing debulking surgery.
Who may be able to join
- Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology)
- BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm
- Patients who pass standard clinical MRI screening procedures
- Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN
- Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN
Who cannot join
- Allergy to FDG or gadolinium
- Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging
- Known kidney disease or poor renal function
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.
Read the detailed description
PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.
- Conditions
- Endometrial Cancer
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of distant metastasis of endometrial cancer by PET/MRI
Preoperative PET/MRI will be read by a radiologist and compared to final pathologic evaluation of metastatic specimens in high risk endometrial cancer patients.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Mariani, Mayo Clinic
- Investigators
- Andrea Mariani, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765698
- Sponsor's protocol ID
- 15-004593
- Status last verified
- Mar 2018
- First submitted
- 5 May 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02765698
- Acronym / sponsor ID
- 15-004593
- Conditions
- Endometrial Cancer
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 May 2016 (estimated)
- 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.
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.
Detailed description
PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with biopsy-proven high risk (type 2 or grade 3 endometrioid histology) endometrial cancer undergoing debulking surgery.
Key inclusion criteria (5 listed)
- Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology)
- BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm
- Patients who pass standard clinical MRI screening procedures
- Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN
- Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN
Key exclusion criteria (4 listed)
- Allergy to FDG or gadolinium
- Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging
- Known kidney disease or poor renal function
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of distant metastasis of endometrial cancer by PET/MRI
Time frame: one month
Preoperative PET/MRI will be read by a radiologist and compared to final pathologic evaluation of metastatic specimens in high risk endometrial cancer patients.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Andrea Mariani principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early. Results are not available in the source record.
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?
Detection of distant metastasis of endometrial cancer by PET/MRI (time frame: one month). 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 27 Mar 2018.