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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04993261
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vikas Kundra
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

Experimental: Diagnostic (dual energy CT scan)

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

Interventions

Procedure: - Dual-Energy Computed Tomography

Undergo dual energy CT scan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Vikas Kundra

vkundra@mdanderson.org

713-745-2702

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