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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaged prior to primary debulking surgery | Experimental | 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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| Imaged pre/postneoadjuvant chemotherapy (NACT) | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Ovarian Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Viktoriya Paroder, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Contrast enhanced CT | Diagnostic Test | Standard of care contrast enhanced CT |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |