Genitourinary System CarcinomaNCT07219134
Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System
An observational study of Genitourinary System Carcinoma and Malignant Pelvic Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study is being done to see if researchers can find a better way to image a patient's tumor during radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genitourinary System Carcinoma, Malignant Pelvic Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 8 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with pelvis or genitourinary cancer requiring standard of care radiotherapy treatment
Who may be able to join
- * 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
Who cannot join
- * Minors, defined as individuals less than 18 years of age
- Pregnant or nursing female
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
This study is being done to see if researchers can find a better way to image a patient's tumor during radiation treatment.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo lower beam energy CBCT scan once during standard of care radiation therapy on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start6 Jun 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary System CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Dess, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219134
- Sponsor's protocol ID
- UMCC 2024.027
- Other IDs
- NCI-2025-03767, HUM00259510
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System
- ClinicalTrials.gov ID
- NCT07219134
- Acronym / sponsor ID
- UMCC 2024.027
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems, Inc.
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 21 Oct 2025 (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 study is being done to see if researchers can find a better way to image a patient's tumor during radiation treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo lower beam energy CBCT scan once during standard of care radiation therapy on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pelvis or genitourinary cancer requiring standard of care radiotherapy treatment
Key inclusion criteria (4 listed)
- * Patients with pelvis or genitourinary (GU) cancer requiring standard of care radiotherapy treatment
Key exclusion criteria (2 listed)
- * Minors, defined as individuals less than 18 years of age
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Image quality- Mean
Time frame: Up to 2 years
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.
Image quality- median
Time frame: Up to 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Robert Dess principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary System Carcinoma and Malignant Pelvic Neoplasm, run by University of Michigan Rogel 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Apr 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Image quality- Mean (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 17 Apr 2026.