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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04993261
Collaborator
(none)
66
Enrollment
1
Location
1
Arm
75.3
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Dual-Energy Computed Tomography
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Dual Energy CT for the Detection of Gastrointestinal Carcinoids
Actual Study Start Date :
Sep 23, 2015
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (dual energy CT scan)

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

Procedure: Dual-Energy Computed Tomography
Undergo dual energy CT scan
Other Names:
  • DECT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Vikas Kundra, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04993261
    Other Study ID Numbers:
    • 2014-0578
    • NCI-2019-02477
    • 2014-0578
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Neuroendocrine Tumors
    Carcinoid Tumor
    Malignant Carcinoid Syndrome
    Serotonin Syndrome

    Study Results

    No Results Posted as of Aug 6, 2021