Clinical trial · Observational
The Role of Hypoxia as a Selective Pressure for TP53 Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low numbers of eligible patients and failure to successfully recruit them.
Summary
Brief summary (as posted)
The study aims to develop scans that tell the investigators about the oxygen content of tumours using Magnetic Resonance Imaging (MRI) and seeing whether regions of low oxygen content are related to mutations in cancer genes such as TP53. MRI is a method of obtaining pictures of inside of the body that shows the appearance and structure of soft tissues. To get the information about the oxygen content of tumours, MRI is carried out while breathing 100% oxygen. The variation of oxygen supply to different regions of the tumour will help the investigators to predict tumour behavior and tumour response to treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Endometriod
- description
- Type I (endometrioid and mucinous carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.
- label
- Serous
- description
- Type II (serous and clear cell carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.
Primary outcomes (1)
- measure
- Establish distinctive patterns of distribution and expression of mutant TP53 between tumour regions with differing levels of oxygenation (as measured by R2*on MRI).
- timeFrame
- Duration of study (24 months)
- description
- Determined at post surgery histology
Secondary outcomes (2)
- measure
- The reproducibility of the R2* measurement, assessed by comparing 2 R2* scans per person
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years of age on the day of signing the informed consent. 2. Histologically confirmed endometroid or serous endometrial cancer. 3. Scheduled to have hysterectomy at the cancer centre 4. Identifiable tumour mass on staging MRI. 5. Voluntarily agreed to participate by giving written informed consent. Exclusion Criteria: 1. Life expectancy of \< 6 months. 2. Ferromagnetic implants, contraindicating MRI 3. Claustrophobia so unable to tolerate MRI 4. Unable to lie flat 5. Ascites sufficient to prevent patient being fitted in the scanner bore 6. Histology unlikely to show variation in TP53 status, or heavily calcified disease. 7. Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. 8. Unresolved bowel obstruction. 9. Currently participating or has participated in a study with an investigational compound or device within 30 days of the start of treatment. 10. History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 11. Unlikely to comply with the requirements of the study.
References
Publications (0)
Data not yet available