Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT01881451 |
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Recruitment Status :
Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : January 8, 2019
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| Condition or disease | Intervention/treatment |
|---|---|
| Ovarian Cancer Ovarian Neoplasms | Drug: 18F-EF5 PET/CT scan Procedure: Optional biopsy |
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.
| 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 |
- 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.
- 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.
- 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
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.
| 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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT01881451
| Canada, British Columbia | |
| BC Cancer Agency - Vancouver Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Principal Investigator: | Anna Tinker, MD, FRCPC | British Columbia Cancer Agency |
Publications:
| Responsible Party: | British Columbia Cancer Agency |
| ClinicalTrials.gov 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 |
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Tumour hypoxia Clear Cell Ovarian Cancer Recurrent Metastatic |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Hypoxia Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Signs and Symptoms, Respiratory Signs and Symptoms Etanidazole Antineoplastic Agents |