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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/25/2018
Start Date:May 2014
End Date:May 2019

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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.


Inclusion Criteria:

- ≥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.

Exclusion Criteria:

- 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

- Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to
reach places [i.e. falciform ligament or porta hepatis], suprarenal retroperitoneal
lymphadenopathy)
We found this trial at
2
sites
500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Evis Sala, MD, PhD
Phone: 212-639-2179
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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