Molecular imaging as scientific infrastructure for clinical development.
PET, SPECT and radiolabelled therapies are not merely diagnostic tools, but integrated platforms combining molecular biology, pharmacokinetics, dosimetry and clinical decision-making.
Imaging as a structural component of the clinical dossier.
The shift towards theranostic models has transformed nuclear medicine into a paradigm of precision medicine — integrating diagnostics and therapy within a single molecular platform.
The clinical development of radiopharmaceuticals requires multicentre harmonisation of PET/SPECT scans, quantitative validation of uptake parameters, pharmacokinetic modelling, patient-specific dosimetric analysis and complete traceability for regulatory submissions.
In this context, imaging is not merely an endpoint but a structural component of the clinical dossier. We support early-phase and pivotal studies, ensuring methodological consistency between diagnostic imaging and therapeutic application.
See our approach
Quantitative standardisation and variability control.
Differences between scanners, reconstruction algorithms, calibration and acquisition parameters can significantly influence quantitative values such as SUV or TBR. We control that variability so a value acquired at one centre is comparable to any other site in the study.
- Site qualification. Phantom studies that qualify each centre before acquisition.
- Cross-site calibration. Validation that aligns scanner output across the network.
- Protocol harmonisation. Acquisition parameters aligned to a single standard.
- Continuous quality control. Ongoing QC of datasets throughout the study.
- Scientific comparability. Quantitative values that hold across every participating centre.
Illustrative interface — sample data, not client results.
The first biological indicator of drug-target interaction.
In nuclear medicine studies, imaging often serves as the earliest read-out of drug-target engagement. Accurate quantification of uptake and biodistribution turns molecular data into clinically relevant information.
Mechanism of action
Quantified uptake that validates how the agent engages its molecular target.
Responsive subgroups
Biodistribution patterns that help identify populations likely to respond.
Go / no-go decisions
Early-phase imaging evidence that supports development decisions.
Biomarker integration
Imaging data combined with molecular biomarkers for a fuller biological picture.
Quantitative analysis
Advanced analysis of uptake and biodistribution across timepoints and sites.
The bridge between efficacy and safety.
We work with medical physicists and clinical centres to implement advanced dosimetric models based on time-activity curves and multi-timepoint quantitative analysis.
In therapeutic nuclear medicine, dosimetry forms the bridge between efficacy and safety. Accurate determination of the absorbed dose per organ and per lesion is essential for optimising the treatment regimen and reducing the risk of toxicity.
Patient-specific assessment supports adaptive treatment strategies and strengthens the regulatory dossier — consistent with the principles of personalised medicine.
Nuclear medicine studies are also subject to particular regulatory scrutiny, especially where therapeutic radiopharmaceuticals are involved. Every step, from instrument calibration to the storage of datasets, must be documented, traceable and subject to inspection.
Nuclear medicine does not tolerate approximation.
It requires the integration of clinical expertise, medical physics, radiopharmacy and data governance. We operate as an independent scientific partner across all four.
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Technically harmonised
PET/SPECT aligned across scanners and centres for comparable quantitation.
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Quantitatively robust
Calibrated, QC’d datasets that keep SUV, TBR and dose values reliable.
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Clinically interpretable
Molecular data translated into clinically meaningful information.
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Regulatorily defensible
Compliant archiving, complete audit trail and support during inspections.
Radioligand therapy trials, published.
PSMA radioligand therapy trials supported by WIDEN, and the imaging analyses published from them. See all publications.
- Predictive value of early PSMA upregulation for the response to enzalutamide ± 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer: substudy of the randomized, phase 2 ENZA-p trial (opens in a new tab)
- Overall survival and quality of life with 177Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial (opens in a new tab)
- Prognostic and predictive value of baseline PSMA-PET total tumour volume and SUVmean in metastatic castration-resistant prostate cancer in ENZA-p (ANZUP1901): a substudy from a multicentre, open-label, randomised, phase 2 trial (opens in a new tab)
- Overall survival with 177Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer (TheraP): secondary outcomes of a randomised, open-label, phase 2 trial (opens in a new tab)
- 177Lu-PSMA-617 plus enzalutamide in patients with metastatic castration-resistant prostate cancer (ENZA-p): an open-label, multicentre, randomised, phase 2 trial (opens in a new tab)
- Sequential 177Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study (opens in a new tab)
- PSMA and FDG-PET as predictive and prognostic biomarkers in patients given 177Lu-PSMA-617 versus cabazitaxel for metastatic castration-resistant prostate cancer (TheraP): a biomarker analysis from a randomised, open-label, phase 2 trial (opens in a new tab)
- 177Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial (opens in a new tab)
- ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901) (opens in a new tab)
- UpFrontPSMA: a randomized phase 2 study of sequential 177Lu-PSMA-617 and docetaxel vs docetaxel in metastatic hormone-naïve prostate cancer (clinical trial protocol) (opens in a new tab)
- TheraP: a randomized phase 2 trial of 177Lu-PSMA-617 theranostic treatment vs cabazitaxel in progressive metastatic castration-resistant prostate cancer (Clinical Trial Protocol ANZUP 1603) (opens in a new tab)
Strengthen the molecular imaging behind your radiopharmaceutical study.
In a rapidly expanding sector, the methodological quality of imaging is a strategic factor. Discover how harmonised, independently governed imaging protects the credibility of your nuclear medicine trial.