Neoplasms Clinical Trial
— IQ-EMBRACEOfficial title:
Quantitative MR Imaging in Locally Advanced Cervical Cancer Sub-study Under the EMBRACE II Protocol
NCT number | NCT03210428 |
Other study ID # | 57480 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 18, 2018 |
Est. completion date | September 2023 |
Verified date | February 2020 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 320 |
Est. completion date | September 2023 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | The Netherlands Cancer Institute |
Denmark,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease control measure | 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 | 5 years | |
Secondary | Radiomics | 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 | 5 years |
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