NCT04430127

Brief Summary

To demonstrate the potential role of dual-energy computed tomography (DECT) by iodine maps data, aimed at discriminating colon cancer from colon wall pseudo-thickening.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

June 10, 2020

Last Update Submit

August 2, 2022

Conditions

Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Difference of iodine uptake

    Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT

    3.11.2021

Study Arms (1)

Colorectal adenocarcinoma

patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging

Other: No supplementary intervention is performed

Interventions

No supplementary intervention is performedOTHER

No supplementary intervention will be applied

Colorectal adenocarcinoma

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the Department of Radiology at our institution from April 2020

You may qualify if:

  • pathology-proved colorectal tumor

You may not qualify if:

  • BMI above 30 kg/m2
  • renal insufficiency (estimated glomerular filtration rate \< 30 ml/min),
  • allergy to iodinated contrast, and a
  • known history of previous abdominal radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonaz Malekzadeh

Fribourg, 1708, Switzerland

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

April 1, 2020

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)