DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

Malignant Neoplasm Clinical Trial

Official title:

Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685539
• Other study ID #: 2018-0303
• Secondary ID: NCI-2018-0198420
• Status: Completed
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: August 29, 2023

Study information

• Verified date: August 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

Description:

PRIMARY OBJECTIVES:

I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions.

Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based "Gamma Knife (GK)" protocol magnetic resonance imaging (MRI).

OUTLINE:

Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient with pathology-proven solid organ cancer

• MRI of the brain with contrast, positive for two or more metastatic lesions

• One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater

• Planned treatment with stereotactic radiosurgery

Exclusion Criteria:

• Known allergy to iodine-based contrast agents

• Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis

• If prior nephrectomy, GFR less than 60

• Prior central nervous system malignancy

• Prior brain radiation

• Pregnant women are excluded

Related Conditions & MeSH terms

• Malignant Neoplasm
• Metastatic Malignant Neoplasm in the Brain
• Neoplasms

Intervention

Procedure:
• Dual-Energy Computed Tomography
Undergo DECT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best diagnostic performance of computed tomography (CT) reconstruction parameters	A repeated-measures analysis of variance with the Dunnett post hoc test will be used to determine the significance of the differences in the signal-to-noise (SNR) and contrast-to-noise (CNR) measurements at the optimal parameter setting, compared with all other parameter settings.	Up to 2 years
Primary	Accuracy of CT	A Bland-Altman analysis will be used to show the agreement of number of lesions between optimal parametrized CT and the one of standard of care magnetic resonance imaging (MRI).	Up to 2 years

External Links

•   MD Anderson Cancer Center