Clinical trial · Interventional
Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
NCT06820385CI-TRIAL-00126331LEOPARD-IGrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fullyet Device and CT Scans | Device | — | UNRESOLVED |
| Fullyet Device and MRI Scans | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Healthy volunteers
- description
- Five healthy volunteers will be enrolled in this study.
- interventionNames
- Device: Fullyet Device and MRI Scans
- type
- EXPERIMENTAL
- label
- Cancer patients
- description
- Ten cancer patients will be enrolled into this study.
- interventionNames
- Device: Fullyet Device and CT Scans
Primary outcomes (1)
- measure
- The number of events showing feasibility
- timeFrame
- Up to 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment. 3. 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. 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol. 2. Inability to place device on skin (excessive hair or body habitus that is prohibitive).
References
Publications (0)
Data not yet available
No reference posted for this study.