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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

Tracking Information
First Submitted Date April 12, 2018
First Posted Date April 24, 2018
Last Update Posted Date January 11, 2019
Actual Study Start Date September 17, 2018
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2018)
  • 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
    1. moderate hypermetabolism
    2. 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Official Title Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Brief Summary Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any patient coming for a PET
Condition Anal Cancer
Intervention Other: questionnary
questionnary on predictif factors about physiological hypermetabolism of anal canal
Study Groups/Cohorts Not Provided
Publications * Aide N, Tainturier LE, Nganoa C, Houdu B, Kammerer J, Galais MP, Ciappuccini R, Lasnon C. HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological (18)F-FDG anal uptake. EJNMMI Res. 2020 Mar 20;10(1):28. doi: 10.1186/s13550-020-0615-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 10, 2019)
644
Original Estimated Enrollment
 (submitted: April 23, 2018)
400
Actual Study Completion Date November 15, 2018
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03506529
Other Study ID Numbers 2017-A03545-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Centre Francois Baclesse
Original Responsible Party Same as current
Current Study Sponsor Centre Francois Baclesse
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Francois Baclesse
Verification Date January 2019