SIMPLICITY MEETS DIAGNOSTICS EXCELLENCE
Isoprotrace is available in the Netherland
Product Overview
Isoprotrace® is a ready-to-use, multi-dose kit for the efficient preparation of Gallium (68Ga) Gozetotide solution for I.V. injection.
Isoprotrace® providing a valuable tool for enhancing diagnostic accuracy and patient care It is indicated for use in Positron Emission Tomography (PET) to detect PSMA-positive lesions in men with prostate cancer, providing a valuable tool for enhancing diagnostic accuracy and patient care.
Active ingredient: 10µg Gozetotide (PSMA-11)
Presentation: Multi-dose sterile vacuum vial
The Package contains: 5 vials
Shelf life: 2 years
Key Features: Fast, Efficient, Reliable
High-Precision PSMA Biomarker:
Contains PSMA-11 for precise prostate cancer diagnosis.
Time and Resource Efficient:
Over 99% yield reduces product loss and handling.
Single Sterile Vacuum Vial:
Ready-to-use, simplifies the labeling process.
Easy Multi-Dose Preparation:
Prepare multiple doses in just 5 minutes
Simplified QC:
RCP with iTLC; no HPLC needed, fewer tests required.
Quality Assured:
Manufactured in FDA-inspected facilities, compliant with EU GMP.
Indications
Isoprotrace® is indicated for PET imaging of PSMA-positive lesions in adult men with prostate cancer:
- Primary staging of patients with high-risk prostate cancer prior to primary curative therapy.
- Suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) level, after primary curative therapy.
Understanding PSMA PET/CT
What is PSMA?
Prostate-Specific Membrane Antigen (PSMA) is a protein highly expressed in prostate cancer cells, makes it a valuable biomarker for both detecting and targeting prostate cancer.
PSMA PET/CT combines the functional imaging capabilities of PET with the anatomical detail of CT, allowing for precise localization of cancerous lesions.
Importance of PSMA Imaging
- High sensitivity and specificity for detecting prostate cancer lesions.
- Useful in both primary staging and recurrence detection.
- Aids in treatment planning and monitoring.
Advanced Imaging Capabilities
Isoprotrace® leverages cutting-edge PSMA-targeted imaging technology to provide:
- High Sensitivity and Specificity: Detect even small metastases with precision¹⁻².
- Whole-Body Scanning: Comprehensive assessment of primary tumors and metastatic spread³⁻⁴.
- Clear Visualization: High-contrast images for accurate interpretation⁵.
- Early Detection: Identify recurrence at lower PSA levels compared to conventional imaging⁶⁻⁷.
Technical Information
Rapid, efficient process from start to finish Rapid, efficient process from start to finish
Radiolabelling
With Gallium-68 (68Ga)
5-Minute Preparation
Rapid, efficient process from
start to finish
Generator Compatibility
Fully compatible with both 68Ge/68Ga
generators approved in Europe
Quality Control
RCP with iTLC (no HPLC needed),
fewer QC tests required
Storage
Store in refrigerator (2°C – 8°C),
before reconstitution
Stability
Up to 4 hours at room
temperature after radiolabelling
FAQ
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Regulatory Information
Isoprotrace® has received marketing authorization in the Netherlands and Germany with pending approvals in more EU countries.
For detailed information, please refer to the product’s SmPC.
References
1. Ida Sonni, Adam B. Weiner, Sahith Doddipalli, Madhvi Deol, David Ban, Hye Ok Kim, Tristan Grogan, Preeti Ahuja, Nashla Barroso, Yang Zong, Priti Soin, Anthony Sisk, Johannes Czernin, William Hsu, Jeremie Calais, Robert E. Reiter, Steven S. Raman. Clinical, Pathologic, and Imaging Variables Associated with Prostate Cancer Detection by PSMA PET/CT and Multiparametric MRI.Journal of Nuclear Medicine Oct 2024, jnumed.124.268443; DOI: 10.2967/jnumed.124.268443.
2. HopeTA, GoodmanJZ, AllenIE, CalaisJ, FendlerWP, CarrollPR.Meta-analysis of 68Ga-PSMA-11 PET accuracy for the detection of prostate cancer validated by histopathology. J Nucl Med. 2019;60(6):786-793. doi:10.2967/ jnumed.118.219501.
3. Al Saffar H, Chen DC, Delgado C, Ingvar J, Hofman MS, Lawrentschuk N, Perera M, Murphy DG, Eapen R. The Current Landscape of Prostate-Specific Membrane Antigen (PSMA) Imaging Biomarkers for Aggressive Prostate Cancer. Cancers. 2024; 16(5):939..
4. HopeTA,EiberM,ArmstrongWR,etal.Diagnosticaccuracyof68Ga-PSMA-11PETforpelvicnodalmetastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial. JAMA Oncol. 2021;7(11):1635-1642. doi:10.1001/jamaoncol.2021.3771.
5. Zhou J, Wu R, Wang W, Zhao Y, Liu X. (68)Ga-PSMA PET/CT for the evaluation of metastasis in patients with prostate cancer: a systematic review and meta-analysis. Hell J Nucl Med. (2022) 25(3):297–311. doi: 10.1967/s002449912525.
6. Kunst N, Long JB, Westvold S, et al. Long-Term Outcomes of Prostate-Specific Membrane Antigen–PET Imaging of Recurrent Prostate Cancer. JAMA Netw Open. 2024;7(10):e2440591. doi:10.1001/jamanetworkopen.2024.40591.