Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy

Anal Cancer Clinical Trial

Official title:

18F-FMISO-PET, 18F-FDG-PET/CT, DWI-MRI and DCE-MRI Scans as Predictors of Response to Radiotherapy +/- Chemotherapy in Patients With Anal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01330186
• Other study ID #: GI 1026
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2011
• Last updated: April 11, 2011
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2011
• Source: Copenhagen University Hospital at Herlev
• Contact: Eva Serup-Hansen, MD
• Phone: +4538689084
• Email: evseha01[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy (Cisplatin and 5-FU).

Description:

The study involves tree MRI sessions, two FDG-PET-CT sessions and one FMISO-PET session. The FMISO-PET session is presently not carried out because of delivery problems. The production of 18F-fluoromisonidazol at The Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Herlev, Denmark has not jet been approved by the Danish Medicines Agency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological confirmation of invasive primary squamous cell carcinoma of the anal canal or perianal region.

• TNM stage T1-4, N0-3, M0-1

• Treatment with curative intent

• Age > 18 years

• Able to provide informed consent

Exclusion Criteria:

• Contraindication to MRI imaging

• Cardiac pacemaker

• Major obesity

• Serious claustrophobia

• Other malignant disease (except non-melanoma skin cancer) in a period of 5 years prior to imaging study

• Poorly regulated diabetes mellitus despite insulin

• Pregnancy

• Breast feeding

• Known allergy to iv contrast agent

• Major psychiatric illness which would prevent participation in the imaging study

• Infectious wounds on the legs

• Unacceptable kidney function

• Major language difficulties which would prevent participation in the imaging study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Other:
• FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)
This study involves 6 imaging sessions. One FMISO-PET before radiation therapy, one FDG-PET-CT before radiation therapy and one FDG-PET-CT during radiation therapy and tree Magnetic Resonance imaging (MRI) sessions with one session before radiation therapy, one session during radiation therapy and one sessions post radiation.

Locations

Country	Name	City	State
Denmark	Department of Oncology Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response	Primary tumor 18-F-deoxyglucose (FDG) uptake before radiation and during week 3 of radiation.; Primary tumor apparent diffusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation; Primary tumor perfusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation; Primary tumor 18-F-Fluoromisonidazol (FMISO) uptake before radiation	6-8 weeks post radiation	No