Pelvic MalignanciesLEOPARD-IGNCT06820385
Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
A study testing Fullyet Device and CT Scans and Fullyet Device and MRI Scans in people with Pelvic Malignancies, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a device feasibility study to determine the feasibility of automatically predicting time to treatment readiness using a wearable imaging device (Fullyet) in both healthy volunteers and patients with pelvic malignancies undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pelvic Malignancies
- What is being tested?
- Fullyet Device and CT Scans and Fullyet Device and MRI Scans
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2025to 30 Oct 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment.
- Patients (not healthy volunteers) can have any pelvic malignancy (e.g., rectal cancer, prostate cancer, bladder cancer, cervical cancer, anal cancer, endometrial cancer, sarcoma, bone metastatic lesions) being treated with radiation therapy.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol.
- Inability to place device on skin (excessive hair or body habitus that is prohibitive).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kevin Rogacki, MD, 414-805-4400, krogacki@mcw.edu
About this study
This is a device feasibility study to determine the feasibility of automatically predicting time to treatment readiness using a wearable imaging device (Fullyet) in both healthy volunteers and patients with pelvic malignancies undergoing radiation therapy.
Read the detailed description
The purpose of this study is to test an experimental wearable, ultrasound-based device to measure the fullness of the bladder. In order to protect organs at risk of damage, treatment timing with pelvic radiation depends on a full bladder each day. Right now, people drink water and guess when their bladders are full. Each day, CT scans are taken immediately before radiation treatment to look at the size and shape of the bladder and rectum. Up to 50% of patients are not ready for treatment. They must return to the waiting area to fill their bladder. Over a typical course of fractionated radiation therapy, patients require five to six extra scans to make sure that the bladder is ready for treatment. Delays can cause stress and anxiety for the patient, as well as the administration of unnecessary CT scans resulting in higher radiation exposure.
- Conditions
- Pelvic Malignancies
- Being tested
- Fullyet Device and CT Scans, Fullyet Device and MRI Scans
- Keywords
- Device feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fullyet Device and CT ScansDevice
Cancer patients will wear the Fullyet Device. Real-time data will go to the patient and radiation therapy team. When the Fullyet Device indicates that the bladder is at optimal size, the radiation oncology team will get the patient. The patient will then have a CT scan.
Fullyet Device and MRI ScansDevice
Healthy volunteers will first have an MRI scan. Then, they will wear the Fullyet Device. They will have up to two more MRIs to confirm bladder volume.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Five healthy volunteers will be enrolled in this study. Receives: Device: Fullyet Device and MRI Scans |
| Cancer patients | Experimental | Ten cancer patients will be enrolled into this study. Receives: Device: Fullyet Device and CT Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of events showing feasibility
The feasibility of acquiring and assessing relative bladder volume and morphology will be measured using the Fullyet wearable imaging device and compared to CT (for patients) or MRI (for healthy volunteers). Specifically, feasibility will be the number of events showing successful data acquisition. A successful data acquisition event refers to the device's ability to approximate bladder size to that measured on the daily cone beam CT (for patients) or MRI (for health volunteers) to approximately ±30%.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start2 May 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic MalignanciesStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll cancer patients who receive CT scans and healthy volunteers who receive MRI scans.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin R. Rogacki, MD, Medical College of Wisconsin
- Investigators
- Kevin Rogacki, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820385
- Sponsor's protocol ID
- PRO00054270
- Acronym
- LEOPARD-IG
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
- ClinicalTrials.gov ID
- NCT06820385
- Acronym / sponsor ID
- LEOPARD-IG / PRO00054270
- Conditions
- Pelvic Malignancies
- Keywords
- Device feasibility study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 11 Feb 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 is a device feasibility study to determine the feasibility of automatically predicting time to treatment readiness using a wearable imaging device (Fullyet) in both healthy volunteers and patients with pelvic malignancies undergoing radiation therapy.
Detailed description
The purpose of this study is to test an experimental wearable, ultrasound-based device to measure the fullness of the bladder. In order to protect organs at risk of damage, treatment timing with pelvic radiation depends on a full bladder each day. Right now, people drink water and guess when their bladders are full. Each day, CT scans are taken immediately before radiation treatment to look at the size and shape of the bladder and rectum. Up to 50% of patients are not ready for treatment. They must return to the waiting area to fill their bladder. Over a typical course of fractionated radiation therapy, patients require five to six extra scans to make sure that the bladder is ready for treatment. Delays can cause stress and anxiety for the patient, as well as the administration of unnecessary CT scans resulting in higher radiation exposure.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will enroll cancer patients who receive CT scans and healthy volunteers who receive MRI scans.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: Fullyet Device and MRI ScansFive healthy volunteers will be enrolled in this study. |
| Cancer patients | Experimental | Device: Fullyet Device and CT ScansTen cancer patients will be enrolled into this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment.
- Patients (not healthy volunteers) can have any pelvic malignancy (e.g., rectal cancer, prostate cancer, bladder cancer, cervical cancer, anal cancer, endometrial cancer, sarcoma, bone metastatic lesions) being treated with radiation therapy.
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (2 listed)
- Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol.
- Inability to place device on skin (excessive hair or body habitus that is prohibitive).
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 |
|---|---|---|
| Fullyet Device and CT ScansCancer patients will wear the Fullyet Device. Real-time data will go to the patient and radiation therapy team. When the Fullyet Device indicates that the bladder is at optimal size, the radiation oncology team will get the patient. The patient will then have a CT scan. | Device | Cancer patients |
| Fullyet Device and MRI ScansHealthy volunteers will first have an MRI scan. Then, they will wear the Fullyet Device. They will have up to two more MRIs to confirm bladder volume. | Device | Healthy volunteers |
Primary outcome
The number of events showing feasibility
Time frame: Up to 2 months
The feasibility of acquiring and assessing relative bladder volume and morphology will be measured using the Fullyet wearable imaging device and compared to CT (for patients) or MRI (for healthy volunteers). Specifically, feasibility will be the number of events showing successful data acquisition. A successful data acquisition event refers to the device's ability to approximate bladder size to that measured on the daily cone beam CT (for patients) or MRI (for health volunteers) to approximately ±30%.
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 15 Sep 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.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Kevin Rogacki, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fullyet Device and CT Scans and Fullyet Device and MRI Scans in people with Pelvic Malignancies, run by Medical College of Wisconsin 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: looking for participants now, as of the sponsor's last update on 15 Sep 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?
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?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of events showing feasibility (time frame: Up to 2 months). 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 15 Sep 2026.