Using Advanced Imaging Studies to Develop a Profile of High-grade Serous Ovarian Cancer

STATUS

Recruiting
participants needed

60
sponsor

Memorial Sloan Kettering Cancer Center

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Updated on 19 February 2024

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cancer

ovarian cancer

carcinoma

ovarian carcinoma

Summary

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.

Details

Condition	Ovarian disorder, Ovarian Cancer, Ovarian Cancer, High Grade Ovarian Serous
Age	18-100 years
Treatment	PET/MRI, Contrast enhanced CT
Clinical Study Identifier	NCT04454450
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	years of age or older
	Histologically confirmed or clinically suspected FIGO stage IIIC-IV HGSOC
	Signed consent to MSK Institutional biospecimen protocols IRB 06-107 and 12-245, and planned to undergo multi-region tissue collection [under the above IRB protocols] and subsequent tissue analysis under 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 other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excluded
	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

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Using Advanced Imaging Studies to Develop a Profile of High-grade Serous Ovarian Cancer