The Role of Quantitative Measures on Dual-energy CT in the Prediction of Colorectal Adenocarcinoma

Rekrutierend

NCT-Nummer:
NCT04430127

Studienbeginn:
April 2020

Letztes Update:
04.08.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hôpital Fribourgeois

Collaborator:
-

Studienlocations
(1 von 1)

Sonaz Malekzadeh
1708 Fribourg
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Sonaz Malekzadeh, MD
Phone: +41783012848
E-Mail: soonazmalakzadeh@gmail.com» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Prospectively, 50 consecutive 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, will be included. The exclusion

criteria are as follows: patients with body mass index (BMI) above 30 kg/m2, patients with

renal insufficiency (estimated glomerular filtration rate < 30 ml/min), allergy to iodinated

contrast and a known history of previous abdominal radiotherapy.

All patients will undergo a staging enhanced thoraco-abdominal CT by 256-slices CTs

(Revolution CT, GE healthcare) at Fribourg hospital. DECTs will be acquired without an enema,

rectal insufflation or oral contrast to have collapsed colorectal wall for further

measurements and to simulate routine clinical practice. No additional screening procedures,

such as a laboratory or diagnostic tests are necessary for the present study.

Upon acquiring 50 patients, CT quantitative assessments will be performed. Initially, data

will be transferred to AW Advantage workstations (GE Healthcare). Thereafter, for each

patient, the iodine map images will be created by post-processing by. All CT quantitative

measurements will be performed independently by two radiologists. Three regions of interest

(ROI) will be applied to colorectal tumor and the normal collapsed colorectal wall (confirmed

previously by colonoscopy) and consequently, the mean of these measurements will be reported.

These measurements correspond to mean iodine uptake of colorectal tumor and normal collapsed

wall, respectively. Finally, the iodine uptake of the tumoral lesion and normal collapsed

wall in each patient will be compared to demonstrate the significant difference in iodine

uptake. Investigators anticipate that the obtained cut-off value will be a new benchmark in

clinical practice, to exclude the colorectal tumors on non-prepared collapsed colon wall and

eliminate the need for a complementary colonoscopy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

. pathology-proved colorectal tumor

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Difference of iodine uptake (Time Frame - 3.11.2021):
Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT

Geprüfte Regime

No supplementary intervention is performed:
No supplementary intervention will be applied

Quelle: ClinicalTrials.gov