Clinical trial · Observational
Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer
NCT01881451CI-TRIAL-00056585terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to slow accrual and access to the study drug.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-EF5 PET/CT scan | Drug | — | UNRESOLVED |
| Optional biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary
- timeFrame
- Baseline
- description
- 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 outcomes (1)
- measure
- Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans.
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDGRAY LH, CONGER AD, EBERT M, HORNSEY S, SCOTT OC. The concentration of oxygen dissolved in tissues at the time of irradiation as a factor in radiotherapy. Br J Radiol. 1953 Dec;26(312):638-48. doi: 10.1259/0007-1285-26-312-638. No abstract available. PMID 13106296
- BACKGROUNDFyles AW, Milosevic M, Wong R, Kavanagh MC, Pintilie M, Sun A, Chapman W, Levin W, Manchul L, Keane TJ, Hill RP. Oxygenation predicts radiation response and survival in patients with cervix cancer. Radiother Oncol. 1998 Aug;48(2):149-56. doi: 10.1016/s0167-8140(98)00044-9. PMID 9783886
- BACKGROUNDHockel M, Schlenger K, Knoop C, Vaupel P. Oxygenation of carcinomas of the uterine cervix: evaluation by computerized O2 tension measurements. Cancer Res. 1991 Nov 15;51(22):6098-102. PMID 1933873
- BACKGROUNDEvans SM, Hahn SM, Magarelli DP, Zhang PJ, Jenkins WT, Fraker DL, Hsi RA, McKenna WG, Koch CJ. Hypoxia in human intraperitoneal and extremity sarcomas. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):587-96. doi: 10.1016/s0360-3016(00)01494-2. PMID 11173159
- BACKGROUNDNordsmark M, Loncaster J, Aquino-Parsons C, Chou SC, Ladekarl M, Havsteen H, Lindegaard JC, Davidson SE, Varia M, West C, Hunter R, Overgaard J, Raleigh JA. Measurements of hypoxia using pimonidazole and polarographic oxygen-sensitive electrodes in human cervix carcinomas. Radiother Oncol. 2003 Apr;67(1):35-44. doi: 10.1016/s0167-8140(03)00010-0. PMID 12758238
- BACKGROUNDKoch CJ, Scheuermann JS, Divgi C, Judy KD, Kachur AV, Freifelder R, Reddin JS, Karp J, Stubbs JB, Hahn SM, Driesbaugh J, Smith D, Prendergast S, Evans SM. Biodistribution and dosimetry of (18)F-EF5 in cancer patients with preliminary comparison of (18)F-EF5 uptake versus EF5 binding in human glioblastoma. Eur J Nucl Med Mol Imaging. 2010 Nov;37(11):2048-59. doi: 10.1007/s00259-010-1517-y. Epub 2010 Jun 29. PMID 20585774