Individuals With Suspected Colorectal DiseasePhase 3CAD-IMPACTNCT01399710
Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography
A Phase 3 study testing CT colonography, colonoscopy and CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy in people with Individuals With Suspected Colorectal Disease, run by im3D S.p.A..
Trial summary
RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individuals With Suspected Colorectal Disease
- What is being tested?
- CT colonography, colonoscopy and CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 651 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Mar 2010
- Phase
- Phase 3
- 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
Who may be able to join
- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening
Who cannot join
- clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
- inflammatory bowel disease
- celiac disease
- evidence of increased risk of harm from colonoscopy
- psychological or physical conditions that contraindicated colonoscopy or CT Colonography
About this study
Official title: Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion
RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity.
PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.
Read the detailed description
Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.
- Being tested
- CT colonography, colonoscopy, CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy
- Keywords
- colorectal cancer, CT colonography, CAD
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT colonographyProcedure or surgery
Participants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm.
colonoscopyProcedure or surgery
Colonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy
CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino ItalyDevice
Each CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions
Secondary outcomes (2)
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Individuals With Suspected Colorectal DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- im3D S.p.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Candiolo Cancer Institute - IRCCS, Bicocca Universiy of Milano, Milan, Italy, Fondazione Salvatore Maugeri, Catholic University, Italy, Valduce Hospital, University of Turin, Italy, University of Roma La Sapienza, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Nuovo Regina Margherita Hospital, University of Pisa, University of Florence, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Daniele Regge, Principal investigator, Institute Institute for Cancer Research and Treatment, Candiolo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399710
- Sponsor's protocol ID
- CAD COLON 001
- Acronym
- CAD-IMPACT
- Status last verified
- Jul 2011
- First submitted
- 15 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Regge D, Della Monica P, Galatola G, Laudi C, Zambon A, Correale L, Asnaghi R, Barbaro B, Borghi C, Campanella D, Cassinis MC, Ferrari R, Ferraris A, Hassan C, Golfieri R, Iafrate F, Iussich G, Laghi A, Massara R, Neri E, Sali L, Venturini S, Gandini G. Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial. Radiology. 2013 Jan;266(1):168-76. doi: 10.1148/radiol.12120376. Epub 2012 Nov 14.
PubMed 23151831
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion
- ClinicalTrials.gov ID
- NCT01399710
- Acronym / sponsor ID
- CAD-IMPACT / CAD COLON 001
- Keywords
- colorectal cancer, CT colonography, CAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- im3D S.p.A.University, hospital or other
- Collaborators
- Candiolo Cancer Institute - IRCCS, Bicocca Universiy of Milano, Milan, Italy, Fondazione Salvatore Maugeri, Catholic University, Italy, Valduce Hospital, University of Turin, Italy, University of Roma La Sapienza, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Nuovo Regina Margherita Hospital, University of Pisa, University of Florence, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Jul 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.
RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity.
PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.
Detailed description
Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening
Key exclusion criteria (5 listed)
- clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
- inflammatory bowel disease
- celiac disease
- evidence of increased risk of harm from colonoscopy
- psychological or physical conditions that contraindicated colonoscopy or CT Colonography
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 |
|---|---|---|
| CT colonographyParticipants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm. | Procedure or surgery | – |
| colonoscopyColonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy | Procedure or surgery | – |
| CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino ItalyEach CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading. | Device | – |
Primary outcome
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions
2 secondary outcomes
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Derived from this study: PubMed 23151831Regge D, Della Monica P, Galatola G, Laudi C, Zambon A, Correale L, Asnaghi R, Barbaro B, Borghi C, Campanella D, Cassinis MC, Ferrari R, Ferraris A, Hassan C, Golfieri R, Iafrate F, Iussich G, Laghi A, Massara R, Neri E, Sali L, Venturini S, Gandini G. Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial. Radiology. 2013 Jan;266(1):168-76. doi: 10.1148/radiol.12120376. Epub 2012 Nov 14.
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.
Daniele Regge principal investigator
Institute Institute for Cancer Research and Treatment, Candiolo, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT colonography, colonoscopy and CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy in people with Individuals With Suspected Colorectal Disease, run by im3D S.p.A..
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399710, which also lists 1 linked publication.
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 22 Jul 2011.