Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System

NCT07219134 | Completed

• 3 other identifiers: UMCC 2024.027NCI-2025-03767HUM00259510
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if researchers can find a better way to image a patient's tumor during radiation treatment.

Conditions

Genitourinary System Carcinoma; Malignant Pelvic Neoplasm

Outcome Measures

Primary Outcomes (2)

• Image quality- Mean

  The primary analysis will compare imaging quality endpoints processed by DE-CBCT and the standard of care SE-CBCT, with the latter representing the standard clinical acquisition. Descriptive statistics will be computed for the image quality metrics from each imaging modality and for the difference in metrics between the modalities. A paired t-test or Wilcoxon signed-rank test will compare the distribution of the image quality metrics between DE-CBCT and standard of care SE-CBCT. Secondary analysis will compare image quality endpoints between DE-CBCT and standard of care conventional planning CT.

  Up to 2 years

• Image quality- median

  The primary analysis will compare imaging quality endpoints processed by DE-CBCT and the standard of care SE-CBCT, with the latter representing the standard clinical acquisition. Descriptive statistics will be computed for the image quality metrics from each imaging modality and for the difference in metrics between the modalities. A paired t-test or Wilcoxon signed-rank test will compare the distribution of the image quality metrics between DE-CBCT and standard of care SE-CBCT. Secondary analysis will compare image quality endpoints between DE-CBCT and standard of care conventional planning CT.

  Up to 2 years

Study Arms (1)

Observational

Patients undergo lower beam energy CBCT scan once during standard of care radiation therapy on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pelvis or genitourinary cancer requiring standard of care radiotherapy treatment

You may qualify if:

• \* Patients with pelvis or genitourinary (GU) cancer requiring standard of care radiotherapy treatment
• All adults, defined as individuals of 18 years of age or greater
• Radiotherapy treatment will be performed on the Varian Ethos radiotherapy system
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• \* Minors, defined as individuals less than 18 years of age
• Pregnant or nursing female

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Varian Medical Systems, Inc.: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Robert Dess

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: October 21, 2025
• Study Start: June 6, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)