Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by British Columbia Cancer Agency
Sponsor:
Collaborator:
Carraressi Foundation OVCARE
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01881451
First received: June 14, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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 use 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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).

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881451

Locations
Canada, British Columbia
BC Cancer Agency - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Anna Tinker, MD, FRCPC    604-877-6000    atinker@bccancer.bc.ca   
Principal Investigator: Anna Tinker, MD, FRCPC         
Sub-Investigator: Christina Parsons, MD, FRCPS         
Sub-Investigator: Paul Hoskins, MD, FRCPC         
Sub-Investigator: Don Wilson, MD, FRCPC         
Sub-Investigator: Francois Benard, MD, FRCPC         
Sub-Investigator: Julian Lum, PhD         
Sponsors and Collaborators
British Columbia Cancer Agency
Carraressi Foundation OVCARE
Investigators
Principal Investigator: Anna Tinker, MD, FRCPC British Columbia Cancer Agency
  More Information

Publications:

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01881451     History of Changes
Other Study ID Numbers: H13-00921
Study First Received: June 14, 2013
Last Updated: November 18, 2013
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Tumour hypoxia
Clear Cell Ovarian Cancer
Recurrent
Metastatic

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014