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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454450
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer High Grade Ovarian Serous Diagnostic Test: PET/MRI Diagnostic Test: Contrast enhanced CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Integration of Radiomic Analysis Into the Multi-Modal Profiling of High-Grade Serous Ovarian Cancer
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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
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 Test: Contrast enhanced CT
Standard of care 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
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 Test: Contrast enhanced CT
Standard of care contrast enhanced CT




Primary Outcome Measures :
  1. Comparison between radiologist tumor segmentation [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ovarian Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454450


Contacts
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Contact: Ines Nikolovski, MBBS 646-888-4989 nikolovi@mskcc.org
Contact: Ricardo Otazo, PhD 646-608-8282

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Ines Nikolovski,, MBBS    646-888-4989      
Contact: Ricardo Otazo, PhD    646-608-8282      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Ines Nikolovski, MBBS Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04454450    
Other Study ID Numbers: 20-212
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
FIGO stage IIIC-IV
PET radiotracer
20-212
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type