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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04993261
Other study ID # 2014-0578
Secondary ID NCI-2019-0247720
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 23, 2015
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Ajaykumar Morani, MD
Email AMorani@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies the use of a special type of computed (CT) scan called dual energy CT in detecting gastrointestinal carcinoid tumors. CT is an imaging technique that uses x-rays and a computer to create images of areas inside the body. Dual energy computed tomography is a technique used during routine CT scans to help obtain and process the image after the scan is complete. Doctors want to learn if dual energy computed tomography can help improve the detection of carcinoid tumors during routine CT scans.


Description:

PRIMARY OBJECTIVES: I. Evaluate prospectively the sensitivity and specificity of dual energy computed tomography (CT) in detecting primary gastrointestinal (GI) carcinoid. OUTLINE: Patients undergo one dual energy CT scan during scheduled CT scan.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with: clinical features of carcinoid syndrome (or) increased serum and urinary markers suggestive of carcinoid (or) endoscopic biopsy proven carcinoid (or) metastases which are biopsy proven as carcinoid. - Patient is scheduled to have a clinically indicated staging CT exam. - Patients who have signed their informed consent form to undergo the study. Exclusion Criteria: - Patients who have already had their primary GI carcinoid resected. - Contraindication to intravenous contrast agents (e.g. allergy, renal failure, dialysis, pregnancy etc.). - Pregnant patients.

Study Design


Intervention

Procedure:
Dual-Energy Computed Tomography
Undergo dual energy CT scan

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors through study completion, an average of 1 year
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