- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454450
Using Advanced Imaging Studies to Develop a Profile of High-grade Serous Ovarian Cancer
Integration of Radiomic Analysis Into the Multi-Modal Profiling of High-Grade Serous Ovarian Cancer
The researchers are doing this study to find out whether the researchers can combine information provided by PET/MRI scans with information from tests on blood and tissue samples to develop a very detailed description (profile) of high-grade serous ovarian carcinoma (HGSOC), which could improve our ability to treat this disease.
The study researchers will use computers to analyze the combined results of the imaging tests and the genetic and immune system tests on the tumor samples. The study researchers think that this information will help them more accurately predict the way tumors respond to treatment, which may improve their ability to individualize treatments for this disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years of age or older
- Histologically confirmed or clinically suspected FIGO stage IIIC-IV HGSOC
- 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
- Plasma glucose ≤200 mg/dL
- Negative pregnancy test, if a patient is of child-bearing potential
Exclusion Criteria:
- Known allergy to gadolinium-based contrast medium requiring premedication or known adverse reactions to gadolinium-based contrast medium.
- Known history of impaired renal function, with documented eGFR <30 within 30 days prior to PET/MRI.
- Patients who cannot give valid informed consent because of general medical or physical condition, or physiologic status unrelated to presence of ovarian cancer
- Patients who are unwilling or unable to undergo PET/MRI including patients with absolute or relative contraindications to MRI including breast tissue expanders, cardiac pacemakers and defibrillators, non MRI-compatible aneurysm clips, neurostimulators, programmable CSF shunts, vascular stents, claustrophobia, or inability to lie flat for the duration of the examination.
- Patients with metallic hardware, implant, or device in the abdomen or pelvis that might distort the local magnetic field and compromise image quality.
- Radiotherapy to the abdomen or pelvis within 12 months of the screening visit.
- Subjects with a current diagnosis of ovarian cancer other than HGSOC
- Patients with known synchronous primary endometrial cancer or past history of endometrial cancer.
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor. Patients may have received prior adjuvant chemotherapy for breast cancer.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with excluded known concurrent malignancy.
- Unresolved bowel obstruction.
- History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study or interfere with patient's participation for the full duration of the study.
- Absence of any target lesions ( ≥1-2 cm) in the pelvis (right adnexa, left adnexa, infra-colic omentum, pelvic peritoneum) visible on staging standard-of-care CE-CT and accessible for tissue sampling at laparoscopy and/or primary/ interval debulking surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Imaged prior to primary debulking surgery
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).
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Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection.For research PET/MRI - standard volumes of gadolinium contrast and fluorodeoxyglucose (FDG) will be administered.
Standard of care contrast enhanced CT
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Experimental: Imaged pre/postneoadjuvant chemotherapy (NACT)
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).
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Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection.For research PET/MRI - standard volumes of gadolinium contrast and fluorodeoxyglucose (FDG) will be administered.
Standard of care contrast enhanced CT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between radiologist tumor segmentation
Time Frame: 1 year
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Radiologist-defined tumor volumes will be used to train and validate a machine learning algorithm for generating segmentations.
The data will be split into 70%-30% of training and test sets, respectively.
The comparisons will be performed on a slice-by-slice and lesion-bylesion basis, which should ensure sufficient numbers of examples for testing.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Viktoriya Paroder, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 20-212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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