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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
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
July 21, 2021
Last Updated
August 23, 2023
Sponsor
M.D. Anderson Cancer Center
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
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
Email
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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