Carcinoid SyndromeEarly Phase 1NCT04993261
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors
A Early Phase 1 study testing Dual-Energy Computed Tomography in people with Carcinoid Syndrome and Carcinoid Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome, Carcinoid Tumor, Digestive System Neuroendocrine Tumor G1
- What is being tested?
- Dual-Energy Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2015to 31 Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dual Energy CT for the Detection of Gastrointestinal Carcinoids
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Carcinoid Syndrome, Carcinoid Tumor, Digestive System Neuroendocrine Tumor G1, Metastatic Carcinoid Tumor
- Being tested
- Dual-Energy Computed Tomography
- Medical subject headings
- Serotonin Syndrome, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy Computed TomographyProcedure or surgery
Also called DECT
Undergo dual energy CT scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (dual energy CT scan) | Experimental | Patients undergo one dual energy CT scan during scheduled CT scan. Receives: Procedure: Dual-Energy Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start23 Sep 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajaykumar Morani, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993261
- Sponsor's protocol ID
- 2014-0578
- Other IDs
- NCI-2019-02477, 2014-0578
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No