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Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT (HYPHYCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506529
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

Condition or disease Intervention/treatment
Anal Cancer Other: questionnary

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Study Type : Observational
Actual Enrollment : 644 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: questionnary
    questionnary on predictif factors about physiological hypermetabolism of anal canal


Primary Outcome Measures :
  1. Description of predictive factors for physiological hypermetabolism of the anal canal in 18F-FDG PET / CT [ Time Frame: Only at the day of inclusion, during an appointment for a TEP exam ]

    Confrontation in participants of hypermetabolism of the anal canal in PET with:

    number of stool/day and consistency of stool, medical history (by Answers to the specific questionnaire designed for the study)


  2. PET analysis of hypermetabolism of the anal canal [ Time Frame: Only at the day of inclusion, during an appointment for a TEP exam ]

    Visual analysis of hypermetabolism of the anal canal on a 3-point scale:

    0: no hypermetabolism

    1. moderate hypermetabolism
    2. intense hypermetabolism

  3. CT scan with measurement [ Time Frame: Only at the day of inclusion, during an appointment for a TEP exam ]
    measurement of the largest rectal diameter in mm.

  4. CT scan with measurement [ Time Frame: Only at the day of inclusion, during an appointment for a TEP exam ]
    Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient coming for a PET
Criteria

Inclusion Criteria:

  • Patient 18 years old
  • Patient referred for 18F-FDG PET

Exclusion Criteria:

  • History of surgery or anal and / or perineal and / or pelvic radiotherapy, whatever the indication
  • Patient deprived of liberty, under tutorship or curatorship
  • Any associated socio-educational, medical or psychological condition that could compromise the patient's ability to participate in the study (eg illiteracy, mental retardation, etc.)
  • Pregnant woman (classic contraindication of a PET scan)
  • Opposition of the patient to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506529


Locations
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France
CHU
Caen, France, 14000
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03506529    
Other Study ID Numbers: 2017-A03545-48
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
TEP
hypermetabolism
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action