An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors

Early Phase 1

Active, not recruiting

• Conditions: Carcinoid Tumor; Digestive System Neuroendocrine Tumor G1; Carcinoid Syndrome; Metastatic Carcinoid Tumor
• Interventions: Procedure: Dual-Energy Computed Tomography

• Registration Number: NCT04993261
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-09-23
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 71

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (dual energy CT scan)	Dual-Energy Computed Tomography	Patients undergo one dual energy CT scan during scheduled CT scan.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States