QUANTITATIVE IMAGING COMPUTING · SHANGHAI, CHINA

Quantitative imaging & dosimetry computation
for pharmaceutical clinical trials

NDMed (NuSight Digital Medical) provides quantitative molecular imaging computation and dosimetry calculation services for radiopharmaceutical IIT and Phase I–III clinical trials, covering quantitative metrics in neuro, cardiac and oncological imaging, multi-site imaging QC and result delivery. Scope is defined per project.

Quantitative imaging · Radiopharmaceutical dosimetry · Multi-site imaging QC · Neuro / Cardiac / Oncology

Quantitative imaging computationQUANTITATIVE IMAGING

Internal radiation dosimetryINTERNAL DOSIMETRY

Multi-site harmonisationMULTI-SITE HARMONISATION

GCP documentation & traceabilityDOCUMENTATION & TRACEABILITY

SERVICE OVERVIEW

Quantitative molecular imaging computation & dosimetry calculation for clinical trials

For radiopharmaceutical IIT and Phase I–III clinical trials. Quantitative scoring (CenTauR, PSMA) and radiopharmaceutical dosimetry calculation belong to this computing service; acquisition parameters, quantitative metrics and result delivery are defined per project.

SERVICE STAGES

  1. 01Protocol design
  2. 02Site qualification
  3. 03Acquisition QC
  4. 04Quantitative computation
  5. 05Result delivery

Acquisition and reconstruction parameters are documented and harmonised across sites; image data handover, quantitative metric definitions and delivery formats are defined per project; QC records are retained for traceability.

COMPUTING SERVICES · CLINICAL TRIALS

Quantitative imaging, dosimetry calculation and imaging QC

Quantitative imaging and internal dose calculation per project protocol, covering protocol harmonisation, phantom-based site qualification, per-timepoint image QC and result delivery. Metrics, implementation and validation are defined per project.

Acquisition & reconstruction protocol design

Develop, review and harmonise acquisition and reconstruction parameters across sites.

PROTOCOL HARMONISATION

Phantom validation & site qualification

EARL / NEMA phantom studies (uniform, NEMA and Hoffman phantoms) to qualify site equipment.

EARL / NEMA PHANTOM QC

Quantitative imaging & analysis

Tumour / organ / lesion quantification, TAC modelling and PBPK analysis, quantitative neuroimaging scoring.

QUANTIFICATION · TAC · PBPK

Internal radiation dosimetry

Organ dose, tumour dose, whole-body retention and effective dose from quantitative PET / SPECT.

INTERNAL RADIATION DOSIMETRY

Y-90 SIRT dose planning & verification

Pre-treatment ⁹⁹ᵐTc-MAA SPECT planning (lung shunt, tumour and normal-liver dose); post-treatment ⁹⁰Y PET verification and voxel dose maps.

PLAN · TREAT · VERIFY

Quantitative scoring services

Quantitative scoring delivered as computing services: CenTauR (tau PET), PSMA PET lesion uptake and enrolment assessment, and result calculation for standardised scales. Metrics, implementation and validation are defined per project.

CENTAUR · PSMA · SCORING SERVICES

QUANTITATIVE SCORING · COMPUTING SERVICES

CenTauRTau PET · cross-tracer standardised scale

PSMAPSMA PET · lesion uptake quantification and enrolment assessment

RPT / RLT
ONCOLOGY TRIALS

Imaging support for RPT oncology trials

Imaging support for RPT oncology studies using ¹⁷⁷Lu · ²²⁵Ac · ²¹¹At · ⁹⁰Y, plus diagnostic isotopes ⁶⁸Ga · ¹⁸F · ⁸⁹Zr and small-molecule, peptide and nanobody agents.

SERVICE FIGURES

Workflow and methodology schematics

Original schematic figures illustrating the workflow and methodology of our computing services. These are not real subject images, measured data or project deliverables.

SCHEMATIC · NOT PATIENT DATA

MULTI-SITE IMAGING QC SITE 01SITE 02SITE 03 PROTOCOL HARMONISATION PHANTOM QC SITE QUALIFICATION CENTRAL QUANTITATIVE COMPUTATION QC RECORDS DELIVERY PROTOCOL / PHANTOM / COMPUTE / DELIVER

Multi-site imaging QC and protocol harmonisation

Acquisition and reconstruction parameters are documented and harmonised across sites; phantom validation, per-timepoint image QC and centralised quantitative computation are defined per project.

TIME-ACTIVITY CURVE TO DOSE ACTIVITYTIMEAUC ORGAN DOSE (SCHEMATIC) KIDNEYLIVER TUMOURMARROW TAC FIT / TIAC / MIRD OR VOXEL DOSE

From time–activity curves to dose results

Serial quantitative images yield fitted time–activity curves and integrated time-integrated activity, then organ or voxel doses. Fitting methods and validation are defined per project.

ROI / VOI AND QUANTITATIVE METRICS LESION CONTOUR (SCHEMATIC, NOT AN IMAGE) METRIC DEFINITION UPTAKESUVTAC / TIAC DEFINED PER PROJECT PROTOCOL UPTAKE / SUV / STANDARDISED SCALES

ROI / VOI and quantitative metric definitions

Lesion, organ and regional uptake quantification depends on contour definition, activity calibration and metric conventions. Metric definitions, implementation and validation are defined per project.

Figures are original NDMed methodology schematics, not real subject images, measured curves or deliverables. Metrics, parameters, validation and deliverables are defined per project.

CLINICAL AREAS

Quantitative computation in neuro, cardiac and oncological imaging

One quantitative computation and QC workflow; imaging metrics, timepoints and deliverables are defined per clinical area and per project.

NEURO · MOLECULAR IMAGING

Neuro molecular imaging

Regional brain PET quantification, longitudinal consistency checks and result calculation for standardised scales (e.g. CenTauR). Metric definitions, implementation and validation are defined per project.

BRAIN PET · STANDARDISED SCALES

CARDIAC · IMAGING

Cardiac imaging

Uptake quantification and multi-timepoint consistency checks for cardiac SPECT / PET. Quantitative metrics and thresholds are defined per project.

CARDIAC SPECT / PET · QC

ONCOLOGY · THERANOSTICS

Oncology & therapeutic isotopes

Tumour / organ / lesion uptake quantification, PSMA PET enrolment assessment support, time–activity curve fitting and internal radiation dosimetry.

LESION UPTAKE · TAC · DOSE

COMPUTING-SERVICE METHODOLOGY

RECONSTRUCTION & DOSIMETRY METHODS

Methodology applied in our computing services

The reconstruction and dosimetry methods NDMed applies in clinical-trial quantitative computation. Parameter choices, implementation and validation are defined per project; each isotope–camera combination is confirmed per project.

METHOD · HYBRID

Organ dose workflow

Serial whole-body / SPECT-CT registration → ROI / VOI → count-to-activity conversion → time–activity curve fitting and integration → MIRD organ dose calculation.

TAC · TIAC · MIRD

METHOD · VOXEL

Voxel dosimetry

Monte Carlo photon transport through the patient CT yields voxel dose maps, DVHs and dose tables, with deformable registration and semi-automatic segmentation. Scope is defined per project.

DOSE MAP · DVH · MC TRANSPORT

METHOD · MONTE CARLO

Monte Carlo computation

Used twice: photon transport for voxel dose, and collimator–detector response modelling in SPECT reconstruction (high-energy isotopes; specific isotope–collimator combinations only).

PHOTON TRANSPORT · COLLIMATOR RESPONSE

METHOD · SPECT

Quantitative SPECT reconstruction

Iterative reconstruction compensates attenuation, collimator blur, scatter and noise; CT attenuation maps, scatter windows and activity / SUV calibration convert counts to quantitative values.

ATTENUATION · SCATTER · CALIBRATION

METHOD · ALPHA

Alpha-emitter quantitative computation

Energy windows, collimators, calibration and reconstruction parameters for ²²⁵Ac, ²¹¹At and ²¹²Pb require verification per camera and protocol.

²²⁵Ac · ²¹¹At · ²¹²Pb

CHAIN · FROM IMAGE TO DOSE

From image to absorbed dose

  1. 01Quantitative SPECT / PET reconstruction and activity calibration
  2. 02Time–activity curve fitting, cumulated activity / residence time
  3. 03Organ dose (MIRD) or voxel dose (Monte Carlo)
  4. 04Dose map, DVH and dose results table

As computing-service methodology

NDMed applies these methods per protocol for quantitative reconstruction, time–activity curve fitting and internal dose calculation. Parameter choices, implementation, validation and delivery formats are defined per project, with QC records and documentation retained.

METHODOLOGICAL APPLICATIONS

Methodological applications in specific scenarios

Methodological scenarios beyond standard dosimetry; whether they are applied is defined per project.

Cross-isotope dose prediction: from Lu-177 to alpha emitters

Lu-177 therapy dose data→Cross-isotope dose modelling→Ac-225 / Pb-212 alpha dose prediction

Using Lu-177 data to support dose exploration and protocol design in alpha-emitter RLT.

Low-dose Lu-177 dosimetry to predict FIH dose

Low-dose Lu-177 imaging→Pharmacokinetic extrapolation→FIH therapeutic dose prediction

Supporting dose escalation for new RLT agents with lower radiation exposure.

PSMA PET-based quantitative RLT enrolment analysis

PSMA PET images→Quantitative lesion uptake assessment→Subject enrolment decision support

Replacing subjective reading with objective numbers for consistent, traceable enrolment.

Single-time-point dosimetry

Single-time-point SPECT / PET→Time–activity curve extrapolation→Organ / lesion dose estimation

Reducing a multi-visit dosimetry workflow to a single imaging session.

This methodology description is drawn from published literature on MIRD organ dosimetry, Monte Carlo particle transport and quantitative SPECT reconstruction; implementation, parameters, validation and deliverables are defined per project, with QC records and documentation retained.

SCOPE

Isotopes, drug formats and trial phases

Diagnostic imaging, beta-minus therapy and alpha therapy isotopes. Confirm the scope for each project.

Diagnostic imaging isotopes

DIAGNOSTIC IMAGING

⁶⁸Ga

¹⁸F

⁸⁹Zr

⁶⁴Cu

β⁻ / Auger therapy isotopes

BETA / AUGER THERAPY

¹⁷⁷Lu

⁹⁰Y

¹⁶¹Tb

Alpha therapy isotopes

ALPHA THERAPY

²²⁵Ac

²¹¹At

²¹²Pb

Drug formats

Small molecules

Peptides

Nanobodies

Clinical areas & trial phases

Oncology

Neuro molecular imaging

Cardiac imaging

IIT

Phase I–III

Isotopes and indications are compiled from company materials and the NDMed WeChat official account; confirm the scope for each project.

QUALITY MANAGEMENT

Quality management of computing and analysis services

Computing and analysis services following GCP

Good Clinical Practice (GCP) for pharmaceutical clinical trials

  • Standardised data management and traceability
  • Qualified, confirmed analysis methods
  • Complete documentation and quality-control procedures

Who we work with

WHO WE WORK WITH

Pharma / sponsorsR&D and clinical development teams

CROsClinical operations and imaging management

Hospitals / nuclear medicineClinical research sites

Research institutionsMedical imaging research

ABOUT US

NDMed · NuSight Digital Medical

Quantitative molecular imaging computing services for clinical trials

NDMed provides quantitative molecular imaging computation and dosimetry calculation services for radiopharmaceutical clinical trials, covering quantitative imaging QC, pharmacokinetic modelling, individualised radiation dose assessment and result delivery. Based in Shanghai, China.

Chinese legal name上海睿观数科医药科技有限公司

English legal nameShanghai NuSight Digital Medical Technology Ltd.

Brand / short nameNDMed · 睿观数科 · NuSight Digital Medical

Project enquiries & collaboration

To discuss a clinical-trial computing service plan, imaging metric definitions or deliverables, please contact us through our WeChat official account.

OFFICIAL WECHAT ACCOUNT

WeChat Official Account: 睿观数科 (NDMed)

Use the Business Cooperation menu item or leave a message. Further technical content is available on the account.