- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01330186
Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy
April 11, 2011 updated by: Copenhagen University Hospital at Herlev
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.
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Herlev, Denmark, 2730
- Recruiting
- Department of Oncology Herlev Hospital
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Contact:
- Eva Serup-Hansen, MD
- Phone Number: +4538689084
- Email: evseha01@heh.regionh.dk
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Contact:
- Hanne Havsteen, MD
- Phone Number: +4538682287
- Email: hahav@heh.regionh.dk
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Principal Investigator:
- Eva Serup-Hansen, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with anal canal or perianal cancer
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anal cancer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: 6-8 weeks post radiation
|
|
6-8 weeks post radiation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
February 1, 2012
Study Completion (Anticipated)
May 1, 2012
Study Registration Dates
First Submitted
April 5, 2011
First Submitted That Met QC Criteria
April 5, 2011
First Posted (Estimate)
April 6, 2011
Study Record Updates
Last Update Posted (Estimate)
April 12, 2011
Last Update Submitted That Met QC Criteria
April 11, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GI 1026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnal Squamous Cell Carcinoma | Stage III Anal Cancer AJCC v8 | Stage IIB Anal Cancer AJCC v8 | Stage IIIA Anal Cancer AJCC v8 | Stage IIIB Anal Cancer AJCC v8 | Stage IIIC Anal Cancer AJCC v8 | Stage I Anal Cancer AJCC v8 | Stage II Anal Cancer AJCC v8 | Stage IIA Anal Cancer AJCC v8 | Stage 0 Anal Cancer...United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedStage III Anal Cancer AJCC v8 | Anal Canal Squamous Cell Carcinoma | Stage IIB Anal Cancer AJCC v8 | Stage IIIA Anal Cancer AJCC v8 | Stage IIIB Anal Cancer AJCC v8 | Stage IIIC Anal Cancer AJCC v8 | Stage I Anal Cancer AJCC v8 | Stage II Anal Cancer AJCC v8 | Stage IIA Anal Cancer AJCC v8United States
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National Cancer Institute (NCI)RecruitingAnal Canal Cloacogenic Carcinoma | Metastatic Anal Squamous Cell Carcinoma | Recurrent Anal Squamous Cell Carcinoma | Stage III Anal Cancer AJCC v8 | Stage IV Anal Cancer AJCC v8 | Unresectable Anal Squamous Cell Carcinoma | Anal Basaloid Squamous Cell CarcinomaUnited States
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Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingAnal Canal Cancer | Anal Squamous Cell Carcinoma | Anal Cancer | Anal Canal Cancer Stage IIIChina
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