Repetitive Functional Imaging in Locally Advanced Cervical Cancer

Repetitive Functional Imaging in Locally Advanced Cervical Cancer - Functional Imaging in Cervical Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40266

Enrollment

Registered

2014-07-08

Start date

2014-03-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix cancer

Interventions

The standard MRI scan which will be repeated 3 times extra (before start RT and twice in FU). All other MRIs are part of regular clinical procedures but have as extra the administration of 15 ml con

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients with locally advanced cervical cancer FIGO stage IB2-IV referred for definitive radio-chemotherapy • Patients where MR guided brachytherapy is part of standard patient treatment • Patients without previous record of allergic reaction to infusion of protocol related contrast media (Gadolinium-based for MR-imaging) • Patients with sufficient kidney function according to local regulations • Patients of 18 years age and over • Cancer of the uterine cervix considered suitable for curative treatment • Positive biopsy showing SQ, AdCA, AdAQ. • Staging according to FIGO and TNM performed • MRI pelvis at diagnosis available • MRI, CT or PET-CT retroperitoneum and abdomen at diagnosis available • MRI pelvis with applicator at BT will be performed • Patient informed consent

Exclusion criteria

Exclusion criteria: • Patients receiving neoadjuvant chemotherapy, hyperthermia or other antineoplastic treatments • Patients with contra indications to MRI • GFR

Design outcomes

Primary

Measure	Time frame
• To evaluate the sensitivity and specificity of DWI-MRI to identify patients who will develop local failure after radio-chemotherapy of cervix cancer	—

Secondary

Measure	Time frame
• To evaluate the sensitivity and specificity of MRI techniques including (T2-weighted MRI, DCE-MRI) to identify patients who will develop local failure after radio-chemotherapy of cervix cancer • Determining whether there are differences in bias between centres. The difference in bias will be assessed for the T1 and T2 scans and the Ktrans and ADC maps. • Comparison of DWI and T2 tumour volume delineation	—

Measure

Time frame

• To evaluate the sensitivity and specificity of MRI techniques including (T2-weighted MRI, DCE-MRI) to identify patients who will develop local failure after radio-chemotherapy of cervix cancer • Determining whether there are differences in bias between centres. The difference in bias will be assessed for the T1 and T2 scans and the Ktrans and ADC maps. • Comparison of DWI and T2 tumour volume delineation

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)