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

NCT01881451TerminatedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

British Columbia Cancer Agency

Enrollment

Start Date

2013-08-01

Completion Date

2016-03-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

18F-EF5 PET/CT scanOptional biopsy

Conditions

Ovarian CancerOvarian Neoplasms

Eligibility

Age Range

19 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary

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.

Time frame: Baseline

Secondary Outcomes

Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans.

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.

Time frame: Baseline

Locations

BC Cancer Agency - Vancouver Centre, Vancouver, Canada

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.