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

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Unknown status

CT.gov ID

NCT01330186

Collaborator

(none)

Enrollment

Location

14.9

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer	Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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.

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Anal cancer	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.

Arm

Intervention/Treatment

Anal cancer

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.

Outcome Measures

Primary Outcome Measures

Tumor response [6-8 weeks post radiation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology Herlev Hospital	Herlev		Denmark	2730

Sponsors and Collaborators

Copenhagen University Hospital at Herlev

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01330186

Other Study ID Numbers:

GI 1026

First Posted:

Apr 6, 2011

Last Update Posted:

Apr 12, 2011

Last Verified:

Apr 1, 2011

Additional relevant MeSH terms:

Anus Neoplasms

Study Results

No Results Posted as of Apr 12, 2011