Benchmarking Intra-tumor Heterogeneity In Ovarian Cancer: Linking In-vivo Imaging Phenotypes With Histology And Genomics

NCT02144311 | Completed

• 1 other identifier: 14-061
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging \[MRI\] and Positron Emission Tomography \[PET\] scans. No direct clinical benefits will come from the results of this study.

Conditions

Ovarian Cancer

Keywords

MRI; FDG PET/CT; histologic heterogeneity; 14-061

Outcome Measures

Primary Outcomes (1)

• Genomic markers of spatial heterogeneity

  by evaluating spatially explicit phenotypic clusters based on a combination of perfusion, diffusion and metabolic tumor profiles (maps) in both ovarian tumors and metastatic peritoneal/omental implants of patients with HGSOC undergoing primary debulking surgery (PDS).

  1 year

Secondary Outcomes (1)

• Histological and immunohistochemical features

  1 year

Study Arms (1)

MRI with DW-MRI & DCE-MRI & FDG PET/CT

EXPERIMENTAL

Study participants will have 1 scan within the 7 days immediately preceding surgery (PET/CT as standard of care and MRI as a research exam). MRI and PET/CT scanning procedures will be identical to those used in routine clinical examinations of the abdomen and pelvis.

Procedure: PET/CT Scan; Procedure: MRI

Interventions

PET/CT Scan PROCEDURE

MRI with DW-MRI & DCE-MRI & FDG PET/CT

MRI PROCEDURE

MRI with DW-MRI & DCE-MRI & FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age on the day of signing the informed consent.
• Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer.
• Scheduled to undergo primary debulking surgery.

You may not qualify if:

• Pregnant patients
• Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of ovarian cancer cannot give valid informed consent
• Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
• Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/
• Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
• Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
• Stage not greater than IB
• No more than superficial myometrial invasion
• No vascular or lymphatic invasion
• No poorly differentiated subtypes, including serous, clear cell, or other FIGO Grade 3 lesions.
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. 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, interfere with patient's participation for the full duration of the study.
• Absence of target lesions (\> 2.0 cm) on staging CT

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (2)

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Hebert Vargas Alvarez, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

US (2)