Crohn DiseaseCACTUS-CDNCT06125678
Correlation of Cross Sectional Imaging and Small Intestinal Contrast Ultrasonography in Known Crohn's Disease
A study testing Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography in people with Crohn Disease and Ultrasound Therapy; Complications, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Small intestinal contrast ultrasound (SICUS) is a modality of intestinal ultrasound (IUS) which does not require any parenteral administration of contrast agent but requires ingestion of around 500 ml of polyethylene glycol (PEG). SICUS does not involve any radiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Ultrasound Therapy; Complications, Computed Tomography
- What is being tested?
- Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jul 2023to 26 Feb 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known small bowel CD beyond reach of standard endoscopy who warrants monitoring of disease status either due to assessment of response to therapy/relapse/new unexplained symptoms, persistent disease activity, prior to switching therapy or deciding on surgical management.
Who cannot join
- Obese patients with poor ultrasound window
- pregnant/lactating mother
- Not willing for CT or enteroclysis examination
- Renal insufficiency precluding CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation and Assessment of Small Bowel Lesion Using Cross Sectional Imaging Techniques Compared to Small Intestinal Contrast Ultrasonography in Known Small Bowel Crohn's Disease(the CACTUS-CD Trial): a Prospective Study
Small intestinal contrast ultrasound (SICUS) is a modality of intestinal ultrasound (IUS) which does not require any parenteral administration of contrast agent but requires ingestion of around 500 ml of polyethylene glycol (PEG). SICUS does not involve any radiation. Computed tomography enteroclysis (CTE) requires colonic cleansing using polyethylene glycol (PEG) followed by infusion of 1.5 litres of PEG via a nasal catheter to distend and properly visualise the small intestine. CTE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. Magnetic resonance enterography (MRE) using PEG followed by 2 liters of oral fluid with mannitol was administered to distend and properly visualize the small intestine. MRE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. On the other hand, SICUS is relatively non-invasive method of small bowel assessment although the accuracy has not been studied prospectively. An earlier retrospective study in which MRE/CTE and SICUS are done within 3 months of each other, SICUS had identified lesions and complications in patients with CD with high levels of sensitivity, specificity, and accuracy compared to CT-enteroclysis (3). These findings need prospective validation. The accuracy of SICUS may be suboptimal due to constant peristalsis in the small intestine. Hence the investigators planned this study to perform SICUS in patients with small bowel CD who otherwise require a MRE/CTE for disease monitoring on the same day before the procedure with the same PEG preparation. If SICUS findings are found to correlate with MRE/CTE findings intros study, SICUS have the potential to replace other modalities for monitoring of small bowel Crohn's disease (CD) and emerge as a cost-effective, easy alternative. The investigators also want to understand the drawbacks and limitations of SICUS in this scenario.
Read the detailed description
Diagnosis, CD site and patient's management shall be made according generally accepted recommendations(4). SICUS shall be performed in all participants by one independent experienced operator (MAM). Colonic cleansing shall be done on night before the examination with Polyethylene glycol (PEG) solution (1 litre). The participants shall be examined after the ingestion of 375 mL (range 250-500 mL) of polyethylene glycol (PEG) in the morning using a convex transducer (2-6 MHz) and a high frequency linear-array transducer for details (5-14 MHz). Median SICUS duration shall be noted. SICUS shall be performed without any additional charges to the participant. CT-Enteroclysis shall be performed in all participants by one independent experienced operator (UK). A 20G needle shall be placed in an antecubital vein and 8-F nasojejunal catheter with aTeflon-covered guide wire shall be positioned under fluoroscopic guidance with the distal extremely located in the distal duodenum/proximal jejunum. Afterward the patient shall be taken into the CT room where hypodense contrast material (1500 mL of PEG) shall be administered manually with 60-mL syringes, with a constant and continuous injection rate of 150 mL/min followed by a flow rate of 200 mL/min until the maximum tolerance of the patient. Just before the examination participants shall receive a smooth muscle relaxant (N butyl 4 scopolamine) to prevent spasms, achieve uniform small bowel distension, and reduce abdominal discomfort. The study shall be performed by a 64-slice multidetector CT with the following scan parameters: collimation 1.25 mm, table feed 39.37 mm/rot, 120 kV, 300 mAs,pitch 0.984:1, rotation time 0.5 s, time of acquisition 12.5 s, FOV 50 cm, matrix 512x512. After the infusion of PEG, CT scan seal be performed before and after the administration of intravenous iodinated contrast material. The contrast-enhanced study shall be acquired 70s after the administration of contrast material (Ultravist 370, Schering AG, Berlin, Germany). Median CT-Enteroclysis duration shall be recorded. Magnetic Resonance enterography (MRE) shall be performed in all participants by one independent experienced operator. The participant shall be fasted for 4-6 h prior to the study. In adults, 2 liters of oral fluid with mannitol shall be administered to distend the bowel loops. Just before the examination participants shall receive a smooth muscle relaxant (Buscopan) to prevent spasms, achieve uniform small bowel distension, and reduce abdominal discomfort. T2, BTFE(axial and coronal sequence),diffusion weighted imaging (DWI)(Coronal sequence), Post contrast (Axial, Coronals and sagittal sequence) will be taken.Median MRE duration shall be recorded.The site of small bowel involvement, maximal bowel wall thickness and complications like stricture and fistula detected by SICUS and MRE/CTE shall be collected and correlated.
- Conditions
- Crohn Disease, Ultrasound Therapy; Complications, Computed Tomography, Magnetic Resonance Imaging
- Being tested
- Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterographyDiagnostic test
First small intestinal contrast enhanced ultrasound shall be done followed by CT enterography or MR enterography
| Study group | Role | What they receive |
|---|---|---|
| Small intestinal contrast enhanced ultrasound followed by cross sectional imaging | Experimental | Patients shall be undergoing small intestinal contrast enhanced ultrasound followed by cross sectional imaging Receives: Diagnostic Test: Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in management decision after cross sectional imaging compared to ultrasound
Percentage of patients in which cross sectional imaging changed the management decision
Measured: Day 1
Secondary outcomes (3)
Correlation between bowel wall thickness in affected area in small intestine between small intestinal contrast ultasonography and cross sectional imaging
Correlation between bowel wall thickness in ultrasonography and cross sectional imaging based on correlation coefficient
Measured: Day 1
Agreement for extent of involvement in affected area of small intestine between small intestinal contrast ultasound and cross sectional imaging
Percentage of patients in which small intestinal ultrasound correctly identified extent of involvement compared to cross sectional imaging
Measured: Day 1
Agreement for detecting complications between small intestinal contrast ultrasound and cross sectional imaging
Percentage of patients in which small intestinal ultrasound correctly identified complications compared to cross sectional imaging
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 Jul 2023
- Primary completion25 Feb 2025
- Study completion26 Feb 2025
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 Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Partha Pal, MD, DrNB, Principal investigator, Asian Institute of Gastroenterology and Asian Healthcare Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125678
- Sponsor's protocol ID
- AIG/IEC-BH&R 49 / 06.2023-04
- Acronym
- CACTUS-CD
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pal P, Mateen MA, Pooja K, Marri UK, Reddy CR, Salman S, Piprikar R, Gupta R, Tandan M, Reddy DN. Correlation and Assessment of Small Bowel Lesions Using Cross-Sectional Imaging Techniques Compared With Small Intestinal Contrast Ultrasonography in Known Crohn's Disease (the CACTUS-CD Study): A Paired, Prospective, Confirmatory Study. Am J Gastroenterol. 2026 Aug 1;121(8):1915-1928. doi: 10.14309/ajg.0000000000003776. Epub 2025 Sep 29.
PubMed 41020653
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation and Assessment of Small Bowel Lesion Using Cross Sectional Imaging Techniques Compared to Small Intestinal Contrast Ultrasonography in Known Small Bowel Crohn's Disease(the CACTUS-CD Trial): a Prospective Study
- ClinicalTrials.gov ID
- NCT06125678
- Acronym / sponsor ID
- CACTUS-CD / AIG/IEC-BH&R 49 / 06.2023-04
- Conditions
- Crohn Disease, Ultrasound Therapy; Complications, Computed Tomography, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- 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.
Small intestinal contrast ultrasound (SICUS) is a modality of intestinal ultrasound (IUS) which does not require any parenteral administration of contrast agent but requires ingestion of around 500 ml of polyethylene glycol (PEG). SICUS does not involve any radiation. Computed tomography enteroclysis (CTE) requires colonic cleansing using polyethylene glycol (PEG) followed by infusion of 1.5 litres of PEG via a nasal catheter to distend and properly visualise the small intestine. CTE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. Magnetic resonance enterography (MRE) using PEG followed by 2 liters of oral fluid with mannitol was administered to distend and properly visualize the small intestine. MRE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. On the other hand, SICUS is relatively non-invasive method of small bowel assessment although the accuracy has not been studied prospectively. An earlier retrospective study in which MRE/CTE and SICUS are done within 3 months of each other, SICUS had identified lesions and complications in patients with CD with high levels of sensitivity, specificity, and accuracy compared to CT-enteroclysis (3). These findings need prospective validation. The accuracy of SICUS may be suboptimal due to constant peristalsis in the small intestine. Hence the investigators planned this study to perform SICUS in patients with small bowel CD who otherwise require a MRE/CTE for disease monitoring on the same day before the procedure with the same PEG preparation. If SICUS findings are found to correlate with MRE/CTE findings intros study, SICUS have the potential to replace other modalities for monitoring of small bowel Crohn's disease (CD) and emerge as a cost-effective, easy alternative. The investigators also want to understand the drawbacks and limitations of SICUS in this scenario.
Detailed description
Diagnosis, CD site and patient's management shall be made according generally accepted recommendations(4). SICUS shall be performed in all participants by one independent experienced operator (MAM). Colonic cleansing shall be done on night before the examination with Polyethylene glycol (PEG) solution (1 litre). The participants shall be examined after the ingestion of 375 mL (range 250-500 mL) of polyethylene glycol (PEG) in the morning using a convex transducer (2-6 MHz) and a high frequency linear-array transducer for details (5-14 MHz). Median SICUS duration shall be noted. SICUS shall be performed without any additional charges to the participant. CT-Enteroclysis shall be performed in all participants by one independent experienced operator (UK). A 20G needle shall be placed in an antecubital vein and 8-F nasojejunal catheter with aTeflon-covered guide wire shall be positioned under fluoroscopic guidance with the distal extremely located in the distal duodenum/proximal jejunum. Afterward the patient shall be taken into the CT room where hypodense contrast material (1500 mL of PEG) shall be administered manually with 60-mL syringes, with a constant and continuous injection rate of 150 mL/min followed by a flow rate of 200 mL/min until the maximum tolerance of the patient. Just before the examination participants shall receive a smooth muscle relaxant (N butyl 4 scopolamine) to prevent spasms, achieve uniform small bowel distension, and reduce abdominal discomfort. The study shall be performed by a 64-slice multidetector CT with the following scan parameters: collimation 1.25 mm, table feed 39.37 mm/rot, 120 kV, 300 mAs,pitch 0.984:1, rotation time 0.5 s, time of acquisition 12.5 s, FOV 50 cm, matrix 512x512. After the infusion of PEG, CT scan seal be performed before and after the administration of intravenous iodinated contrast material. The contrast-enhanced study shall be acquired 70s after the administration of contrast material (Ultravist 370, Schering AG, Berlin, Germany). Median CT-Enteroclysis duration shall be recorded. Magnetic Resonance enterography (MRE) shall be performed in all participants by one independent experienced operator. The participant shall be fasted for 4-6 h prior to the study. In adults, 2 liters of oral fluid with mannitol shall be administered to distend the bowel loops. Just before the examination participants shall receive a smooth muscle relaxant (Buscopan) to prevent spasms, achieve uniform small bowel distension, and reduce abdominal discomfort. T2, BTFE(axial and coronal sequence),diffusion weighted imaging (DWI)(Coronal sequence), Post contrast (Axial, Coronals and sagittal sequence) will be taken.Median MRE duration shall be recorded.The site of small bowel involvement, maximal bowel wall thickness and complications like stricture and fistula detected by SICUS and MRE/CTE shall be collected and correlated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small intestinal contrast enhanced ultrasound followed by cross sectional imaging | Experimental | Diagnostic Test: Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterographyPatients shall be undergoing small intestinal contrast enhanced ultrasound followed by cross sectional imaging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known small bowel CD beyond reach of standard endoscopy who warrants monitoring of disease status either due to assessment of response to therapy/relapse/new unexplained symptoms, persistent disease activity, prior to switching therapy or deciding on surgical management.
Key exclusion criteria (4 listed)
- Obese patients with poor ultrasound window
- pregnant/lactating mother
- Not willing for CT or enteroclysis examination
- Renal insufficiency precluding CT
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 |
|---|---|---|
| Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterographyFirst small intestinal contrast enhanced ultrasound shall be done followed by CT enterography or MR enterography | Diagnostic test | Small intestinal contrast enhanced ultrasound followed by cross sectional imaging |
Primary outcome
Change in management decision after cross sectional imaging compared to ultrasound
Time frame: Day 1
Percentage of patients in which cross sectional imaging changed the management decision
3 secondary outcomes
Correlation between bowel wall thickness in affected area in small intestine between small intestinal contrast ultasonography and cross sectional imaging
Time frame: Day 1
Agreement for extent of involvement in affected area of small intestine between small intestinal contrast ultasound and cross sectional imaging
Time frame: Day 1
Agreement for detecting complications between small intestinal contrast ultrasound and cross sectional imaging
Time frame: Day 1
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 16 Jul 2025.
- Derived from this study: PubMed 41020653Pal P, Mateen MA, Pooja K, Marri UK, Reddy CR, Salman S, Piprikar R, Gupta R, Tandan M, Reddy DN. Correlation and Assessment of Small Bowel Lesions Using Cross-Sectional Imaging Techniques Compared With Small Intestinal Contrast Ultrasonography in Known Crohn's Disease (the CACTUS-CD Study): A Paired, Prospective, Confirmatory Study. Am J Gastroenterol. 2026 Aug 1;121(8):1915-1928. doi: 10.14309/ajg.0000000000003776. Epub 2025 Sep 29.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Partha Pal, MD, DrNB principal investigator
Asian Institute of Gastroenterology and Asian Healthcare Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography in people with Crohn Disease and Ultrasound Therapy; Complications, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 4 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 16 Jul 2025. 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 India. 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?
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?
Change in management decision after cross sectional imaging compared to ultrasound (time frame: Day 1). 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 NCT06125678, 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 16 Jul 2025.