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

Copenhagen University Hospital at Herlev

Status: Unknown

Conditions: Anal Cancer

Treatments: Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other

Identifiers

NCT01330186

GI 1026

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Anal cancer

Treatment:

Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)