ActivityPrescriptionChecker

Activity Prescription

activity brachytherapy dosimetry radiopharma source calibration TG-43
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Activity Prescription Checker — Radiopharmaceutical Therapy Dose Verification (EMA, SNMMI)

ℹ️  The utility checks dose per kg body weight, renal function (GFR), cumulative dose, and minimum cycle intervals.
ℹ️  Does not use machine learning — clinical protocol rules only (Lu-177, Ac-225).
⚠️  Critical for theranostics! Dose calculation errors lead to nephrotoxicity or treatment inefficacy. Strict renal function control is mandatory!

Usage:
  ActivityPrescriptionChecker.exe                            → demo mode (console output)
  ActivityPrescriptionChecker.exe input.csv output.json      → evaluate your data

Input format:
PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate

Example (CycleNumber > 1 requires LastTreatmentDate):
PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z

— WHY IS THIS NEEDED?
Prescribing radiopharmaceutical therapy (Lu-177-PSMA, Lu-177-DOTATATE, Ac-225) requires precise activity calculation:
• Dose per kg body weight — baseline efficacy parameter
• Renal function (GFR) — key safety factor (isotopes excreted by kidneys)
• Cumulative dose — limit for entire treatment course (bone marrow/kidney protection)
• Cycle interval — recovery time (min 6–8 weeks)
⚠️ CRITICAL:
• GFR < 60 ml/min — dose reduction by 25–50% required
• GFR < 15 ml/min — therapy contraindicated!
• Exceeding cumulative dose (>45 GBq for Lu-177) — risk of irreversible myelosuppression
• Interval < 6 weeks — high toxicity risk
Critical parameters:
• Dose per kg: 7.4 MBq/kg ±10% (for Lu-177)
• GFR: ≥60 ml/min (full dose), 30–59 (reduction), <15 (prohibited)
• Cumulative dose: ≤45 GBq (Lu-177), ≤15 MBq (Ac-225)
• Cycle interval: ≥42 days
⚠️ Note: Utility automatically calculates correction factor for renal impairment and compares cumulative dose against toxicity limits. Result includes status (APPROVED/WARNING/REJECTED) and specific recommendation.

input.csv

PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate
PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z
PT-2026-046,80.0,175.0,85.0,7400,Lu177,1,0,2025-12-01T10:00:00Z

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: ActivityPrescriptionCheckerAPI / object: Activity PrescriptionCategory: Radiation physics

1. Scope

The Activity Prescription Checker utility is used for Activity Prescription. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Radiation physics

Tags: activity, brachytherapy, dosimetry, radiopharma, source calibration, TG-43

2. Execution modes

ActivityPrescriptionChecker.exe                            → demo mode (console output)
ActivityPrescriptionChecker.exe input.csv output.json      → evaluate your data

3. Key controlled areas

  • pH and physicochemical parameters
  • activity, decay and radiochemical purity

4. Domain limits and critical parameters

  • ⚠️ Critical for theranostics! Dose calculation errors lead to nephrotoxicity or treatment inefficacy. Strict renal function control is mandatory!
  • ⚠️ CRITICAL:
  • GFR < 60 ml/min — dose reduction by 25–50% required
  • GFR < 15 ml/min — therapy contraindicated!
  • Exceeding cumulative dose (>45 GBq for Lu-177) — risk of irreversible myelosuppression
  • Interval < 6 weeks — high toxicity risk
  • Critical parameters:
  • Dose per kg: 7.4 MBq/kg ±10% (for Lu-177)
  • GFR: ≥60 ml/min (full dose), 30–59 (reduction), <15 (prohibited)
  • Cumulative dose: ≤45 GBq (Lu-177), ≤15 MBq (Ac-225)
  • Cycle interval: ≥42 days
  • ⚠️ Note: Utility automatically calculates correction factor for renal impairment and compares cumulative dose against toxicity limits. Result includes status (APPROVED/WARNING/REJECTED) and specific recommendation.
Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

IDRequirementCriticalityAcceptance criterion
URS-001The system shall accept an input.csv file for Activity Prescription with the exact columns listed in the “Input data contract” section.HighA file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002The system shall support execution without arguments in demo mode and execution with input.csv output.json for user data.MediumBoth execution scenarios produce a predictable result or clear diagnostic error.
URS-003The system shall perform rule-based controls for: pH and physicochemical parameters, activity, decay and radiochemical purity.HighEach controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.HighOutput includes batch identifier, source values, parameter statuses and critical findings.
URS-005The system shall generate machine-readable output.json for LIMS/ELN/MES, batch record and QA/QC review.HighJSON contains overall status, check array, warnings, failures and source-file reference.
URS-006The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.HighThe document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007The system shall clearly separate technical data errors from specification nonconformities.MediumSchema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#ColumnTypeUnitDescriptionSampleControl rule
1PatientIDtextas specifiedPatient IDPT-2026-045mandatory value; format and acceptability are checked by the utility
2WeightKgdecimalas specifiedWeight Kg95.0mandatory numeric value; rule comparison is performed by the utility
3HeightCmdecimalas specifiedHeight Cm180.0mandatory numeric value; rule comparison is performed by the utility
4GFR_MLMindecimalminGFR MLMin42.0mandatory numeric value; rule comparison is performed by the utility
5PrescribedActivityMBqdecimalMBqPrescribed Activity MBq7400mandatory numeric value; rule comparison is performed by the utility
6Radionuclidetextas specifiedRadionuclideLu177mandatory value; format and acceptability are checked by the utility
7CycleNumberdecimalas specifiedCycle Number3mandatory numeric value; rule comparison is performed by the utility
8PreviousDoseMBqdecimalMBqPrevious Dose MBq14800mandatory numeric value; rule comparison is performed by the utility
9LastTreatmentDatedate/timeas specifiedLast Treatment Date2026-02-20T09:00:00Zmandatory value; format and acceptability are checked by the utility

CSV example

PatientID,WeightKg,HeightCm,GFR_MLMin,PrescribedActivityMBq,Radionuclide,CycleNumber,PreviousDoseMBq,LastTreatmentDate
PT-2026-045,95.0,180.0,42.0,7400,Lu177,3,14800,2026-02-20T09:00:00Z

7. FS — functional specification

IDFunctionImplementation description
FS-001CLI entry pointThe executable ActivityPrescriptionChecker.exe supports demo mode and input.csv output.json processing mode.
FS-002CSV parserThe import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003Field conversionEach column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004Domain rule engineFor Activity Prescription, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005Criticality handlingCritical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006JSON writeroutput.json stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007Integration contractThe CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008Error handlingSchema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "ActivityPrescriptionChecker",
  "api": "Activity Prescription",
  "batchNumber": "",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "PatientID",
      "value": "PT-2026-045",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "WeightKg",
      "value": "95.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "HeightCm",
      "value": "180.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "GFR_MLMin",
      "value": "42.0",
      "unit": "min",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PrescribedActivityMBq",
      "value": "7400",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclide",
      "value": "Lu177",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "CycleNumber",
      "value": "3",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PreviousDoseMBq",
      "value": "14800",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

IDScenarioExpected result
TC-001Valid CSV with expected header and sample rowAll rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002A mandatory input.csv column is missingImport is rejected or the row receives FAIL with schema reference.
TC-003A numeric field contains text or a blank valueType conversion error is recorded; the result is not hidden as PASS.
TC-004A parameter is outside specification or critical limitCritical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-008Incorrect activity, reference time or radiochemical purityFAIL/WARNING is produced with calculation traceability.

10. QA/QC, CSV and change control

  • Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
  • Column names must not be changed without updating the validator and test scenarios.
  • The source CSV, output.json and utility version should be stored together as an evidence package.
  • Any change in control rules must go through change control and repeated OQ scenario verification.

Included in packages

Radiation Physics QC Suite

Utilities for activity, dosimetry, brachytherapy sources, small-field corrections and TG-43 parameters.

Open

Radiology QC Suite

QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

Open

RPH isotope family: alpha-emitting therapy

Ac-225, Ra-223, At-211, Bi-213 and Th-227: targeted alpha therapy and daughter/recoil control.

Open

RPH isotope family: beta-emitting therapy

Lu-177, Y-90, Ho-166, Re-188, Sm-153, Sr-89, P-32, Cu-67 and Tb-161.

Open

RPH organ/system: bone and musculoskeletal

Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.

Open

RPH organ/system: endocrine, thyroid and NET

Radioiodine, thyroid/parathyroid, somatostatin receptor, MIBG and neuroendocrine workflows.

Open

RPH organ/system: oncology and theranostics

Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.

Open

RPH organ/system: renal and urinary

Renography, GFR/ERPF, renal uptake, DMSA/MAG3/DTPA and bladder-related workflows.

Open

RPH use case: PET scanner state, gamma camera and radiation physics

The linked medical-device/radiation-physics layer: PET detector QC, normalization, AC map, cross-calibration, TOF, gamma-camera uniformity, source strength and staff dose.

Open

RPH workflow: dosimetry and therapy planning

Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.

Open

RPH workflow: instruments, devices and radiation safety

PET/gamma-camera state, calibration, detector QC, energy window, TOF, shielding and radiation safety.

Open