Repetitive Functional Imaging in Locally Advanced Cervical Cancer (IMAP)

November 15, 2013 updated by: Jesper Kallehauge, Aarhus University Hospital

Multicenter Validation of Repetitive Functional Imaging in Locally Advanced Cervical Cancer

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • University Hospitals Leuven
        • Contact:
        • Principal Investigator:
          • Karin Haustermans, Prof.
  • Denmark
      • Aarhus, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Jacob C. Lindegaard, M.D.
          • Phone Number: +45 78462577
          • Email: jacolind@rm.dk
        • Contact:
        • Principal Investigator:
          • Jacob C. Lindegaard, senior M.D.
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Not yet recruiting
        • The Netherlands Cancer Institute
        • Contact:
          • Uulke v.d. Heide, Ph.D.
          • Phone Number: + 31 (0) 20 512 2350
          • Email: u.vd.heide@nki.nl
        • Principal Investigator:
          • Uulke v.d. Heide, Ph.D:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced cervical cancer eligible for chemo-radiotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor volume
Time Frame: pre-treatment, week2, week5, week6, week 7
pre-treatment, week2, week5, week6, week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Universitaire Ziekenhuizen KU Leuven
The Netherlands Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20100251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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