Anal CancerNCT01330186
Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy
An observational study of Anal Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anal canal or perianal cancer
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology Herlev Hospital
Herlev, 2730
Eva Serup-Hansen, MD, +4538689084, evseha01@heh.regionh.dk
Hanne Havsteen, MD, +4538682287, hahav@heh.regionh.dk
About this study
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.
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).
Read the 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.
- Conditions
- Anal Cancer
- Being tested
- FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)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.
| Study group | Role | What they receive |
|---|---|---|
| Anal cancer | Not described Receives: Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-8 weeks post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330186
- Sponsor's protocol ID
- GI 1026
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01330186
- Acronym / sponsor ID
- GI 1026
- Conditions
- Anal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal cancer | – | Other: FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anal canal or perianal cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Anal cancer |
Primary outcome
Tumor response
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Serup-Hansen, MD (+4538689084, evseha01@heh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 6-8 weeks post radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.