NCT06125678: CACTUS-CD

Correlation of Cross Sectional Imaging and Small Intestinal Contrast Ultrasonography in Known Crohn's Disease

Completed NA Last updated 16 July 2025

What this trial tests

NA trial testing Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography in Crohn Disease in 407 participants. Completed in 26 February 2025.

Timeline

20 July 2023

Primary endpoint
25 February 2025

26 February 2025

Quick facts

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	407
Start date	20 July 2023
Primary completion	25 February 2025
Estimated completion	26 February 2025
Sites	1 location across India

Drugs / interventions tested

• Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Ultrasound Therapy; Complications — all drugs for Ultrasound Therapy; Complications →
• Computed Tomography — all drugs for Computed Tomography →
• Magnetic Resonance Imaging — all drugs for Magnetic Resonance Imaging →

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 75, any sex, with Crohn Disease or Ultrasound Therapy; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Pal P, Mateen MA, Pooja K, Marri UK, et al · · 2025 · cited 1× · PMID 41020653 · DOI 10.14309/ajg.0000000000003776
2. UEG Week 2025 Moderated Posters
   · 2025