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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dual Energy CT for the Detection of Gastrointestinal Carcinoids
- ClinicalTrials.gov ID
- NCT04993261
- Acronym / sponsor ID
- 2014-0578
- Conditions
- Carcinoid Syndrome, Carcinoid Tumor, Digestive System Neuroendocrine Tumor G1, Metastatic Carcinoid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (dual energy CT scan) | Experimental | Procedure: Dual-Energy Computed TomographyPatients undergo one dual energy CT scan during scheduled CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Energy Computed TomographyAlso: DECTUndergo dual energy CT scan | Procedure or surgery | Diagnostic (dual energy CT scan) |
Primary outcome
Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajaykumar Morani principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.