SAMPLE — fictional case for illustration. Structure only: no dose has been calculated and nothing here is a clinical finding. Research / Demonstration Only.
UpThera · Clinical Physics & Dosimetry
Extravasation Physics Assessment
Preliminary technical summary · Case EXT-SAMPLE-0001
1. Case summary
- Facility
- Example Medical Center (fictional)
- Case reference
- INC-SAMPLE-0001 (no patient identifiers are used)
- Radiopharmaceutical
- Pluvicto (Lu-177 vipivotide tetraxetan)
- Prescribed / administered activity
- 7,400 MBq / 7,400 MBq (fictional)
- Incident
- Suspected extravasation at the injection site
- Requested by
- Nuclear medicine technologist, on behalf of the Authorized User
2. Information received
- Administration timeline
- Start and end times, and when the extravasation was suspected
- Injection site
- Location, vascular access, dimensions and how they were measured
- Clinical observations
- As reported by the facility
- Measurements
- Imaging, survey and probe readings, each with its time and instrument
- Status
- Awaiting measurements
3. Method
Absorbed dose to the tissue at the site is estimated with the MIRD formalism: the time-integrated activity in the source region multiplied by the S-value for the target and source geometry. Each S-value is cited with its units, reference geometry and source. No mass scaling is applied to a value outside the geometry it was derived for.
The activity-versus-time curve is built from the measurements received. Where clearance was not measured, the report names the scenario used and treats it as an assumption, not a measurement.
4. Assumptions and limitations
- Each assumption is listed with the result it affects.
- Activity before the first measurement, and the geometry of the deposited activity, are stated as assumptions unless they were measured.
- Skin dose is reported at a stated depth, only with validated depth-dose data.
5. Results
- Extravasated activity
- Pending assessment
- Time-integrated activity
- Quantitative estimate unavailable — validated source data required.
- Local tissue absorbed dose
- Quantitative estimate unavailable — validated source data required.
- Skin dose at stated depth
- Quantitative estimate unavailable — validated source data required.
6. Uncertainty and sensitivity
The spread of the estimate across clearance scenarios and input ranges is reported here, with the main contributors named.
7. Regulatory review considerations
Reportability requires assessment of the applicable regulatory criteria, clinical circumstances, license conditions, and jurisdiction. Absorbed dose alone does not automatically determine Medical Event status.
This report supports the facility’s review. It does not classify the event, and the decision on reporting rests with the licensee.
8. Review and signature
- Prepared by
- Medical physicist (name and credentials on a signed report)
- Reviewed by
- Qualified medical physicist
- Signature
- Unsigned sample