Clinical trial NCT01881451: Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer
Official title: Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Ovarian Neoplasms
Keywords: Tumour hypoxia
Clear Cell Ovarian Cancer
Recurrent
Metastatic
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Carraressi Foundation OVCARE
First posted: 2013-06-19
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants with recurrent or metastatic clear cell ovarian cancer will be approached for study participation at the time of their visit with their treating oncologist (medical oncologist, radiation oncologist or gynecologic oncologist).

Brief summary: The purpose of this study is to use 18F-EF5 PET/CT scans to locate areas with low oxygen levels (hypoxia) in patients with recurrent and/or metastatic cancer.

Detailed description: This study involves one visit to the BCCA - Vancouver Centre to undergo one EF5-PET/CT scan. The visit will take about 4 hours to complete and no follow-up visits are required.

* Participants will fill out a short medical questionnaire asking routine information (treatment history, previous surgeries, medications, allergies, etc.) that will take about 5-10 minutes to complete.
* Next they will be weighed and vital signs measured (blood pressure, heart rate and blood oxygen saturation).
* An IV is inserted into a vein in the participant's arm. At the same, a small amount of blood will be taken to measure their blood glucose level.
* The participant will receive an IV dose of 18F-EF5.
* Five minutes after the injection, blood pressure and heart rate will be checked again.
* Participants will then be free to leave the functional imaging department for a period of 180 minutes while the 18F-EF5 circulates throughout their body. Participants are free to eat as normal during this period.
* Participants will undergo the 18F-EF5 PET scan, which will take about 20 minutes. The participant will need to lie still on the scanner bed during the entire scan.
* The 18F-EF5 PET scan will be reviewed by a BC Cancer Agency doctor specialized in PET and the results will be sent to their referring doctor.

Optional Biopsy Procedure:

Participants will have the opportunity of participating in an optional biopsy procedure for the purposes of further studying contemporaneous tumour tissue (contemporaneous with the EF5-PET) for markers of hypoxia, apoptosis, angiogenesis etc. The tissue will also be compared to archival material, and this will allow researchers to study the evolving changes in tumours following treatment.

Patients who consent to undergo a biopsy will be booked to the Diagnostic Imaging Department at the Vancouver Centre. Ultrasound guidance will be used to obtain up to 5 core biopsies from an accessible lesion(s). Up to 2 distinct tumour areas may be sampled. The standard procedure required for a core biopsy will be followed, which will include pre-biopsy lab tests, sterile technique, and when needed, post biopsy observation.

The core biopsies will be formalin fixed and paraffin embedded (FFPE). A BCCA pathologist will review representative slides of each paraffin block to ensure the presence of tumour tissue. The FFPE block will then be sent to the laboratory for immunohistochemistry staining and further interpretation.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, advanced metastatic or recurrent clear cell cancer of the ovary
* At least one index lesion measuring 2 cm in diameter
* Must be able to provide written informed consent, and willing to comply with protocol procedures of the study
* Off all active therapy for at least 4 weeks (cytotoxic chemotherapy, radiation, immune therapy, hormone therapy, clinical trials or new agents)

Exclusion Criteria:

* Renal failure (eGFR \< 50mls/min)
* Patients with unknown primaries
* Previous history of cancer, except treated non-melanoma skin cancer, non-invasive breast cancer, non-invasive cervical cancer; or curatively treated solid cancer with no evidence of recurrence for more than 5 years.
* Receiving or had received active therapy in the form or chemotherapy or radiation within 4 weeks of the PET scan
* ECOG status ≥ 3
* Unable to tolerate a PET scan which involves an injection of radiopharmaceutical and lying flat and still for 30 minutes.
* Weight more than 204.5 kg (Physical Limitation of Imaging and Radiotherapy Couches) or cannot fit through the PET/CT machine (diameter 70cm).
* Patient is pregnant or breastfeeding

Primary outcomes:
measure: Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary
timeFrame: Baseline
Secondary outcomes:
measure: Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans.
timeFrame: Baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Anna Tinker, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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