Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT (HYPHYCA)
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ClinicalTrials.gov Identifier: NCT03506529 |
Recruitment Status :
Completed
First Posted : April 24, 2018
Last Update Posted : January 11, 2019
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Condition or disease | Intervention/treatment |
---|---|
Anal Cancer | Other: questionnary |
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 |

- Other: questionnary
questionnary on predictif factors about physiological hypermetabolism of anal canal
- 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)
- 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
- moderate hypermetabolism
- intense hypermetabolism
- 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.
- 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).

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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 |
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

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
France | |
CHU | |
Caen, France, 14000 | |
Centre François Baclesse | |
Caen, France, 14076 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
TEP hypermetabolism |
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 |