Radiopharmaceutical & Theranostics Imaging Review
Advancing Theranostics Clinical Trials —
As theranostics reshape oncology by combining targeted diagnostics and therapeutics through radiopharmaceuticals, clinical trials demand specialized imaging expertise that few CROs can offer. MERIT is that partner. With 14+ years of imaging endpoint expertise, a network of 300+ readers including board-certified Nuclear Medicine Physicians and Physicists, and our proprietary EXCELSIOR™ platform, MERIT delivers the precision, compliance, and speed your theranostics program requires.
30+ Radiopharmaceutical Studies
Phase I-III Full Trial Coverage
300+ Worldwide Readers
1500+ Collective Clinical Studies Completed
Theranostics Imaging Expertise
Specialized Diagnostic & Therapeutic Assessment
MERIT’s Nuclear Medicine team brings deep expertise across the full theranostic workflow from pre-therapy imaging to post-treatment response evaluation.
- PSMA-targeting agents for prostate cancer visualization and therapy
- Somatostatin receptor (SSTR) tracers for neuroendocrine tumors
- L-amino acid transporter (LAT) imaging for neuro-oncology
- Copper-64 (64-Cu), Gallium-68 (68-Ga), Zirconium-89 (89-Zr), and other diagnostic imaging radioisotope tracers for solid tumor and immuno-oncology
- Lutetium-177 (177-Lu) and other therapeutic radioisotope treatment response monitoring
- Novel tumor-specific tracers under development
Dosimetry & QC Services
Radiopharmaceutical Dosimetry
MERIT supports complete dosimetry workflows for both alpha and beta emitters, following MIRD Committee and ICRP guidelines.
- Vendor-neutral PET/SPECT image quantification
- Semi-automated organ and lesion segmentation
- Organ and tumor dosimetry
- Patient-specific voxel-based dosimetry
- MIRD phantom-based dosimetry
Imaging Acquisition QC
- Imaging and injection parameter verification
- Site certification and scanner calibration oversight
- Support for all diagnostic and therapeutic radioisotopes
Response Criteria
- RECIST 1.1, iRECIST, mRECIST: solid tumors
- PCWG3, PCWG4: prostate cancer
- RANO, RANO 2.0, PET RANO 1.0: neuro-oncology
- Lugano classification and other hematologic response criteria
Recent Radiopharmaceutical & Theranostics Study Experience
MERIT’s reader team has contributed to 30+ theranostics and radiopharmaceutical studies spanning all major tumor types and novel tracer programs:
| Indication | Tracer / Assessment | Phase |
| Prostate Cancer | PSMA-targeting tracer (PET/CT) | I–III |
| Solid Tumors | 89-Zr tracer lesion detectability (PET/CT, PET/MR) | II |
| Advanced Solid Tumorss | 177-Lu treatment + 89-Zr tracer lesion detection | Ib |
| Glioma | 18-F FET tracer for lesion characterization (PET/CT, PET/MR) | EAP |
| Renal Cell Carcinoma | 89-Zr tracer for renal mass assessment (PET/CT) | EAP |
| Neuroendocrine Tumors | SSTR tracers for tumor visualization & response | I–III |
MERIT’s proprietary cloud-based technology platform is purpose-built for complex oncology imaging trials, including theranostics.
Key Capabilities for Theranostics
- Configurable workflows supporting two-reader, three-reader, consensus, and adjudication paradigms for theranostic efficacy and companion diagnostic tracer reads
- Integrated query management with real-time site notifications
- 24/7 sponsor access to study progress and imaging data
- Automated image transfer to sponsor data warehouses
- Complete audit trail from scan receipt to final read
- FDA 510(k)-cleared; ISO 13485-compliant QMS, ISO 27001-compliant ISMS
Centralized Image Storage
MERIT’s innovative Centralized Image Storage Solution is ideal for early-phase theranostics studies, preserving images for future central review, demonstrated to reduce costs by 60% in prospective/retrospective hybrid trials.
Clinical Operations & Quality
MERIT’s operations team is an extension of your study team, managing every aspect of imaging trial conduct.
Study Design & Documentation
- Imaging Charter with theranostics-specific read workflows
- Site imaging guidelines for PET/SPECT acquisition standardization
- Reader training tailored to tracer-specific protocols
- Risk monitoring built into all study call cadences
Regulatory Readiness
- Supporting >200 FDA/EMEA filings across 1,500+ studies
- Sponsor and regulatory agency audit support
- Compliant data privacy, business continuity, and access controls
Why MERIT for Theranostics?
- Experienced imaging CRO with integrated dosimetry + imaging review
- Turnkey capability from Phase I FIH through BLA submission
- Partnerships with 30+ general CROs for seamless integration
Partner with the Imaging Experts
Contact us at moc.orctirem@ygolocno to discuss your theranostics trial