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

NCT ID: NCT01330186

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Anal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Anal cancer

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Department of Oncology, Herlev Hospital

Locations

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Department of Oncology Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Eva Serup-Hansen, MD

Role: CONTACT

+4538689084

Hanne Havsteen, MD

Role: CONTACT

+4538682287

Facility Contacts

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Eva Serup-Hansen, MD

Role: primary

+4538689084

Hanne Havsteen, MD

Role: backup

+4538682287

Other Identifiers

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GI 1026

Identifier Type: -

Identifier Source: org_study_id

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