NCT04993261

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for early_phase_1

Timeline
8mo left

Started Sep 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Sep 2015Dec 2026

Study Start

First participant enrolled

September 23, 2015

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

11.3 years

First QC Date

July 21, 2021

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of dual energy computed tomography in detecting primary gastrointestinal carcinoid tumors

    through study completion, an average of 1 year

Study Arms (1)

Diagnostic (dual energy CT scan)

EXPERIMENTAL

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

Procedure: Dual-Energy Computed Tomography

Interventions

Undergo dual energy CT scan

Also known as: DECT
Diagnostic (dual energy CT scan)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Serotonin SyndromeCarcinoid Tumor

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Ajaykumar Morani

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 6, 2021

Study Start

September 23, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations