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Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell 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. Read our disclaimer for details. Identifier: NCT01881451
Recruitment Status : Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : January 8, 2019
Carraressi Foundation OVCARE
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.

Condition or disease Intervention/treatment
Ovarian Cancer Ovarian Neoplasms Drug: 18F-EF5 PET/CT scan Procedure: Optional biopsy

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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : May 2020

Intervention Details:
  • Drug: 18F-EF5 PET/CT scan
    Patients will undergo an investigations 18F-EF5 PET/CT scan.
  • Procedure: Optional biopsy
    Patients who choose to participate, will undergo a tissue biopsy.

Primary Outcome Measures :
  1. Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary [ Time Frame: Baseline ]
    18F-EF5 uptake will be evaluated semi-quantitatively by determining the tumor-to-muscle activity ratio (T/M). Standardized uptake values (SUV) will be calculated for suspicious areas using a region of interest drawn around the target area on the PET images where SUV = (peak activity/mL in region of interest) / (injected activity/g of body weight). A Tumor-to-muscle ratio of >1.5 is considered positive.

Secondary Outcome Measures :
  1. Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans. [ Time Frame: Baseline ]
    Archival tumour tissue will be obtained with consent when possible/available. New biopsies will be obtained as part of the optional consent process, when safe. Archival and new tumour tissue will be assessed using multi-parameter staining for LC3A/B (autophagy), EF5 (hypoxia) and cleaved caspase 3 (apoptosis). Whenever tumour availability is not limited, we will comprehensively assess gene expression involved in hypoxia, angiogenesis, autophagy, apoptosis, and chemotherapy resistance.

Biospecimen Retention:   Samples With DNA
The collection of archival tumour blocks from the time of prior surgery/biopsy and any newly obtained biopsies (newly obtained biopsies are optional) will be used to construct a tumour tissue microarray (TMA). The TMA will be assessed using multi-parameter staining for LC3A/B (autophagy), EF5 (hypoxia) and cleaved caspase 3 (apoptosis).

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:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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

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 identifier (NCT number): NCT01881451

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Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Carraressi Foundation OVCARE
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Principal Investigator: Anna Tinker, MD, FRCPC British Columbia Cancer Agency


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Responsible Party: British Columbia Cancer Agency Identifier: NCT01881451     History of Changes
Other Study ID Numbers: H13-00921
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2018
Keywords provided by British Columbia Cancer Agency:
Tumour hypoxia
Clear Cell Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Signs and Symptoms, Respiratory
Signs and Symptoms
Antineoplastic Agents