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Advanced Imaging for Ovarian Cancer
N/A
Waitlist Available
Led By Viktoriya Paroder, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Signed consent to MSK Institutional tissue banking protocol IRB# 06-107 and signed or planned to sign IRB# 12-245, and planned to undergo multi-region tissue collection [under the above IRB protocols] and plan to undergo subsequent tissue analysis under biospecimen IRB# 15-200.
Staging standard-of-care contrast-enhanced CT of abdomen and pelvis (+/-chest) available in picture archiving and communication system (PACS) that was obtained at our institution as a part of standard-of-care work-up or submitted for from the outside
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying whether a PET/MRI scan can help create a detailed description of high-grade serous ovarian cancer to improve treatment.
Who is the study for?
This trial is for adults over 18 with advanced high-grade serous ovarian carcinoma (HGSOC). Participants must have had a CT scan at the study's institution, agree to tissue banking, and plan to undergo multi-region tissue collection. Pregnant women are excluded, as well as those unable to consent or undergo PET/MRI scans due to medical devices or conditions like claustrophobia.Check my eligibility
What is being tested?
The trial aims to create a detailed profile of HGSOC by combining PET/MRI imaging with blood and tissue tests. This could lead to more personalized treatments by predicting tumor response better. Researchers will use computer analysis on imaging results alongside genetic and immune system tests from tumors.See study design
What are the potential side effects?
While this study focuses on imaging and sample testing rather than drug interventions, potential side effects may include reactions related to contrast agents used in CT scans such as allergic reactions or kidney issues in individuals with pre-existing conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have agreed to donate my tissue for research and will undergo multiple tissue collections.
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I have a CT scan of my abdomen, pelvis, and possibly chest in the hospital's system.
Select...
My ovarian cancer is at an advanced stage (IIIC-IV).
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison between radiologist tumor segmentation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Imaged prior to primary debulking surgeryExperimental Treatment2 Interventions
Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).
Group II: Imaged pre/postneoadjuvant chemotherapy (NACT)Experimental Treatment2 Interventions
In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/MRI
2013
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,798 Total Patients Enrolled
72 Trials studying Ovarian Cancer
56,885 Patients Enrolled for Ovarian Cancer
Viktoriya Paroder, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Ines Nikolovski, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar level should be no higher than 200 mg/dL.I have no other cancers except for non-melanoma skin cancer.I have had chemotherapy for cancer in my abdomen, pelvis, or as a breast cancer treatment.I don't have any large tumors in my pelvis that can be seen on a CT scan and sampled during surgery.You cannot have a PET/MRI scan if you have breast tissue expanders, pacemakers, defibrillators, certain types of clips, neurostimulators, programmable CSF shunts, vascular stents, claustrophobia, or cannot lie flat during the scan.I have agreed to donate my tissue for research and will undergo multiple tissue collections.I have a CT scan of my abdomen, pelvis, and possibly chest in the hospital's system.If you could become pregnant, you need to have a negative pregnancy test.I currently have a blockage in my intestines that hasn't been fixed.My kidney function is low, with an eGFR below 30 recently.I have or had endometrial cancer along with another primary cancer.I don't have any health issues that would affect the study or stop me from fully participating.My ovarian cancer is at an advanced stage (IIIC-IV).I am 18 years old or older.I have not had radiation to my abdomen or pelvis in the last year.You have metal objects in your abdomen or pelvis that could affect the quality of the images taken during the study.I am allergic to gadolinium-based contrast used in MRIs.My ovarian cancer diagnosis is not high-grade serous ovarian cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Imaged pre/postneoadjuvant chemotherapy (NACT)
- Group 2: Imaged prior to primary debulking surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being accepted for this experiment?
"As indicated on clinicaltrials.gov, this particular medical trial is not recruiting right now; the listing was first posted on June 22nd 2020 and most recently edited on March 2nd 2022. Currently, there are 680 other studies actively seeking participants across various sites."
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