Active, not recruitingNCT04454450Updated Jun 2, 2026

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

An interventional study of PET/MRI and Contrast enhanced CT in Ovarian Cancer and High Grade Ovarian Serous, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Non-randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Conditions studied

Ovarian Cancer
High Grade Ovarian Serous

Browse trials for

Ovarian Neoplasms 2,695

Keywords

FIGO stage IIIC-IV
PET radiotracer
20-212

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

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).
Diagnostic Test: PET/MRI · Diagnostic Test: Contrast enhanced CT
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).
Diagnostic Test: PET/MRI · Diagnostic Test: Contrast enhanced CT

Interventions

Diagnostic testPET/MRI
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.
Diagnostic testContrast enhanced CT
Standard of care contrast enhanced CT

What researchers measure

Primary outcomes

Comparison between radiologist tumor segmentation
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.
Time frame: 1 year

Study locations

1 site

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065, United States

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04454450
Lead sponsor: Memorial Sloan Kettering Cancer Center
Responsible party: Sponsor
First posted: Jul 1, 2020
Start date: Jun 22, 2020
Primary completion: Jun 2027 (estimated)
Completion: Jun 2027 (estimated)
Last update: Jun 2, 2026

Study contacts

Viktoriya Paroder, MD

principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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