Clinical trial · Observational
Quantitative MR Imaging in Locally Advanced Cervical Cancer
Quantitative MR Imaging in Locally Advanced Cervical Cancer Sub-study Under the EMBRACE II Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and metastatic disease control in several cancer sites. Radioresistant hypoxic cells diminish the rate of local control, and the hypoxia driven increase in metastatic potential of the tumour and lowers the rate of distant disease control. DCE MR imaging has been used to quantify the extent of poor perfusion regions within cervical tumours and it has been shown to be a surrogate of hypoxia. Furthermore, a number of studies have demonstrated that DCE MR is predictive of disease failure in cervix cancer. The EMBRACE II study will implement an imaging sub-study, which will evaluate the value of quantitative MR imaging to identify patients at increased risk of disease recurrence (local, nodal and systemic).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Functional Magnetic Resonance Imaging | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease control measure
- timeFrame
- 5 years
- description
- To evaluate the sensitivity and specificity of dynamic contrast enhanced (DCE-MRI) to identify patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer
Secondary outcomes (1)
- measure
- Radiomics
- timeFrame
- 5 years
- description
- To apply radiomics for identification of patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer. Radiomics analysis will include features from DCE-MRI, DWI and quantitative T2 imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients included in the EMBRACE study (see inclusion criteria in the EMBRACE protocol) * Patients without previous record of allergic reaction to infusion of protocol related contrast media (Gadolinium-based) * Patients with sufficient kidney function according to local regulations * Patient informed consent Exclusion Criteria: * According to EMBRACE II protocol * Patients with active infection or severe medical condition
References
Publications (33)
- BACKGROUNDMayr NA, Huang Z, Wang JZ, Lo SS, Fan JM, Grecula JC, Sammet S, Sammet CL, Jia G, Zhang J, Knopp MV, Yuh WT. Characterizing tumor heterogeneity with functional imaging and quantifying high-risk tumor volume for early prediction of treatment outcome: cervical cancer as a model. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):972-9. doi: 10.1016/j.ijrobp.2011.08.011. Epub 2011 Dec 28. PMID 22208967
- BACKGROUNDMayr NA, Wang JZ, Zhang D, Grecula JC, Lo SS, Jaroura D, Montebello J, Zhang H, Li K, Lu L, Huang Z, Fowler JM, Wu DH, Knopp MV, Yuh WT. Longitudinal changes in tumor perfusion pattern during the radiation therapy course and its clinical impact in cervical cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):502-8. doi: 10.1016/j.ijrobp.2009.04.084. Epub 2009 Sep 21. PMID 19775824
- BACKGROUNDAndersen EK, Hole KH, Lund KV, Sundfor K, Kristensen GB, Lyng H, Malinen E. Dynamic contrast-enhanced MRI of cervical cancers: temporal percentile screening of contrast enhancement identifies parameters for prediction of chemoradioresistance. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e485-92. doi: 10.1016/j.ijrobp.2011.05.050. Epub 2011 Oct 17. PMID 22014954
- BACKGROUNDLoncaster JA, Carrington BM, Sykes JR, Jones AP, Todd SM, Cooper R, Buckley DL, Davidson SE, Logue JP, Hunter RD, West CM. Prediction of radiotherapy outcome using dynamic contrast enhanced MRI of carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):759-67. doi: 10.1016/s0360-3016(02)02972-3. PMID 12377328
- BACKGROUNDTakayama Y, Ohno T, Kishimoto R, Kato S, Yoneyama R, Kandatsu S, Tsujii H, Obata T. Prediction of early response to radiotherapy of uterine carcinoma with dynamic contrast-enhanced MR imaging using pixel analysis of MR perfusion imaging. Magn Reson Imaging. 2009 Apr;27(3):370-6. doi: 10.1016/j.mri.2008.07.007. Epub 2008 Sep 2. PMID 18768283
- BACKGROUNDSemple SI, Harry VN, Parkin DE, Gilbert FJ. A combined pharmacokinetic and radiologic assessment of dynamic contrast-enhanced magnetic resonance imaging predicts response to chemoradiation in locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):611-7. doi: 10.1016/j.ijrobp.2009.04.069.