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

Primary Purpose

Carcinoid Syndrome, Carcinoid Tumor, Digestive System Neuroendocrine Tumor G1

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dual-Energy Computed Tomography

About this trial

This is an interventional diagnostic trial for Carcinoid Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (dual energy CT scan)

Arm Description

Patients undergo one dual energy CT scan during scheduled CT scan.

Outcomes

Primary Outcome Measures

Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors

Secondary Outcome Measures

Full Information

NCT ID

NCT04993261

First Posted

July 21, 2021

Last Updated

August 23, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04993261

Brief Title

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

Official Title

Evaluation of Dual Energy CT for the Detection of Gastrointestinal Carcinoids

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 23, 2015 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoid Syndrome, Carcinoid Tumor, Digestive System Neuroendocrine Tumor G1, Metastatic Carcinoid Tumor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (dual energy CT scan)

Arm Type

Experimental

Arm Description

Patients undergo one dual energy CT scan during scheduled CT scan.

Intervention Type

Procedure

Intervention Name(s)

Dual-Energy Computed Tomography

Other Intervention Name(s)

DECT

Intervention Description

Undergo dual energy CT scan

Primary Outcome Measure Information:

Title

Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ajaykumar Morani, MD

AMorani@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajaykumar Morani

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ajaykumar Morani

Phone

713-563-1412

AMorani@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Ajaykumar Morani

12. IPD Sharing Statement

Learn more about this trial

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

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