MedDataX Logo

Repetitive Functional Imaging in Locally Advanced Cervical Cancer

NCT ID: NCT01989364

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging (DWI-MR) has been shown to correlate with cellular density. The ADC is indicative of Gross Tumour Volume (GTV), and preliminary data shows that the dynamics of DWI volumes during treatment (shrinkage) as well as dose to DWI volumes has impact on treatment outcome.

Hypoxic tumour cells within the primary tumour have been identified to have prognostic importance for local control Tumour hypoxia is caused by insufficiency of the tumour vasculature leading to both chronic diffusion limited and acute flow limited hypoxia. 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. Functional imaging has the potential to visualise radioresistant tumour subvolumes. PET scanning (18F-FAZA) is hypothesized to visualise hypoxic tumour subvolumes, and dynamic contrast enhanced (DCE) MR imaging has been used to quantify the extent of poor perfusion regions within cervical tumours.

Objectives:

Primary:

Sensitivity and specificity of functional imaging (18F-FAZA PET (optional), T1w, T2w, DWI-MRI and DCE-MRI) to identify tumours with good and bad response to radio-chemotherapy

Secondary:

Determining whether there are differences in bias between centre. The difference in bias will be assessed for the T1 and T2 scans and the Ktrans and ADC maps.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jesper Kallehauge

Ph. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

The Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium Denmark Netherlands

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karin Haustermans, Prof.

Role: primary

Jacob C. Lindegaard, M.D.

Role: primary

Jesper F. Kallehauge, Ph.D.

Role: backup

Uulke v.d. Heide, Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M-20100251

Identifier Type: -

Identifier Source: org_study_id