Trial record 19 of 249 for:    Open Studies | "Uterine Cervical Neoplasms"

Repetitive Functional Imaging in Locally Advanced Cervical Cancer (IMAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Aarhus University Hospital
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Jesper Kallehauge, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01989364
First received: November 15, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition
Uterine Cervical Neoplasms

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Multicenter Validation of Repetitive Functional Imaging in Locally Advanced Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Tumor volume [ Time Frame: pre-treatment, week2, week5, week6, week 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with locally advanced cervical cancer eligible for chemo-radiotherapy

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989364

Locations
Belgium
University Hospitals Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Karin Haustermans, Prof.    16 3 46902 ext +32    karin.haustermans@med.kuleuven.be   
Principal Investigator: Karin Haustermans, Prof.         
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Jacob C. Lindegaard, M.D.    78462577 ext +45    jacolind@rm.dk   
Contact: Jesper F. Kallehauge, Ph.D.       jespkall@rm.dk   
Principal Investigator: Jacob C. Lindegaard, senior M.D.         
Netherlands
The Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Uulke v.d. Heide, Ph.D.    20 512 2350 ext + 31 (0)    u.vd.heide@nki.nl   
Principal Investigator: Uulke v.d. Heide, Ph.D:         
Sponsors and Collaborators
Aarhus University Hospital
The Netherlands Cancer Institute
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Jesper Kallehauge, Ph. D., Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01989364     History of Changes
Other Study ID Numbers: M-20100251
Study First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014