Repetitive Functional Imaging in Locally Advanced Cervical Cancer

NCT01989364UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Aarhus University Hospital

Enrollment

50

Start Date

2011-01-01

Completion Date

2016-02-01

Study Type

OBSERVATIONAL

Official Title

Multicenter Validation of Repetitive Functional Imaging in Locally Advanced Cervical Cancer

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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 and tracers (Gadolinium-based for MR-imaging, FAZA (when performed))
* 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 Squamous cell carcinoma, Adeno cell carcinoma, Adeno Squamous cell carcinoma.
* 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 Brachytherapy timepoint will be performed
* Patient informed consent

Exclusion Criteria:

* Patients with contra indications to MRI and FAZA-PET (when performed)
* Patients with active infection or severe medical condition
* Patients pregnant, lactating or with childbearing potential without adequate contraception.
* Other primary malignancies
* Metastatic disease beyond paraaortic region (L1-L2)
* Previous pelvic radiotherapy
* Previous total or partial hysterectomy
* Combination of preoperative radiotherapy with surgery
* Patients receiving Brachytherapy only
* Patients receiving External Beam radio therapy only
* Patients receiving neoadjuvant chemotherapy, hyperthermia or other antineoplastic treatments not approved by the Embrace study committee
* Contra indications to BT

Outcome Measures

Primary Outcomes

Tumor volume

Time frame: pre-treatment, week2, week5, week6, week 7

Locations

University Hospitals Leuven, Leuven, Belgium

Aarhus University Hospital, Aarhus, Denmark

The Netherlands Cancer Institute, Amsterdam, Netherlands

Repetitive Functional Imaging in Locally Advanced Cervical Cancer