Diagnostic products

• Production, Quality Control, and Clinical Evaluation of the Radiopharmaceutical ¹⁸FET

Specific imaging of glioma tumors (a broad group of brain and spinal cord tumors).

• Production, Quality Control, and Clinical Evaluation of the Radiopharmaceutical Florbetapir ¹⁸FBP.

This radiopharmaceutical is used to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline, enabling rapid PET imaging-based diagnosis of Alzheimer’s.

 

• Production and Quality Control of the Radiopharmaceutical ¹⁸FES (Fluoroestradiol)

Fluoroestradiol (16α-[18F]-Fluoro-17β-estradiol) is an estrogen analog and the first F-18 PET imaging agent used to detect estrogen receptor (ER)-positive lesions, aiding biopsy guidance in patients with recurrent or metastatic breast cancer.

 

• Production, Quality Control, and Clinical Evaluation of the Radiopharmaceutical ¹⁸F-piridaz.

This drug is used for diagnosing cardiac conditions such as heart failure, coronary artery diseases, and other heart-related disorders using PET imaging systems. Due to its accuracy, reliability, and high-speed imaging capability, this project is currently one of the most significant initiatives in the pharmaceutical and cardiac imaging industry.

 

• Production, Quality Control, and Clinical Evaluation of the Radiopharmaceutical M¹⁸FBG

This diagnostic radiopharmaceutical, based on PET imaging systems, enables rapid and high-resolution imaging of norepinephrine transporter-expressing tumors. It can contribute to the development of a new and useful imaging tool for the diagnosis and monitoring of neuroblastoma.

 

• Production and Quality Control of a New Cold Kit Formulation (EC) for ⁶⁸Ga-Labeling

Design of a new formulation of the EC kit for labeling with gallium-68, with easy-to-use instructions for use in nuclear medicine centers equipped with PET systems, to diagnose and monitor kidney function and possible obstructions in the flow of urine.

 

• Design and Development of a PSMA Kit for 68Ga-Labeling

The Pars-GalluGen generator is one of the company’s key products, and upgrading/optimizing the generator and its related processes is essential. The favorable physical properties and reliable availability of generator-derived 68Ga make it an attractive radionuclide for new PET tracer development. More critical than developing new tracers is establishing simple, reproducible labeling methods to ensure stable production of gallium-based peptide radiopharmaceuticals.

The objective of this project is to produce PSMA kits for labeling with gallium obtained from the Pars GalluGen generator, with activities of 25 and 50 mCi. Efforts will be made to ensure that the resulting kits enable the production of ⁶⁸Ga-PSMA for the detection of metastatic prostate cancer tumors in the simplest possible manner and with high reproducibility.

 

• Design and Development of a DOTATATE kit for labeling with ⁶⁸

The Pars-GalluGen generator is one of the company’s key products, and upgrading and advancing the generator and its related processes is a current necessity. The interesting physical properties and availability of gallium-68 from the generator make it an attractive core for developing new PET tracers. More important than developing new tracers is establishing simple, reproducible labeling methods to ensure stable production of gallium-based peptide products.

The objective of this project is to produce a DOTATATE kit for labeling with gallium obtained from the Pars GalluGen generator, with activities of 25 and 50 mCi. Efforts will be made to ensure that the resulting kits enable the production of ⁶⁸Ga-DOTATATE for the diagnosis of neuroendocrine tumors in the simplest possible manner and with high reproducibility.

 

• Preparation and biological evaluation of ⁶⁸Ga-labeled RGD peptide

The RGD peptide binds to αvβ3 integrin receptors, which are highly expressed on activated endothelial cells (during angiogenesis) and certain cancer cells. Using PET imaging, this peptide enables visualization of tumors undergoing angiogenesis.

 

• Synthesis of the active pharmaceutical ingredient (API) and production of the HMPAO radiopharmaceutical kit for labeling with 99mTc

In recent years, several radiopharmaceuticals have been used for the diagnosis and imaging of brain diseases, one of the most important being hexamethylpropyleneamine oxime (HMPAO). This active compound, labeled with the radionuclide technetium-99m, is widely used in cerebral blood flow imaging and the diagnosis of other brain disorders. Although the synthesis of this active compound is highly challenging and its purification is difficult, successfully synthesizing it could open new horizons in the development and localization of novel radiopharmaceuticals at Pars Isotope Company.

 

• Production and Quality Control of the Radiopharmaceutical ^99mTc-PHC-102
  

^99mTc-PHC-102 is a diagnostic peptide-based radiopharmaceutical for clear cell renal cell carcinoma (ccRCC). This radiopharmaceutical consists of a small organic ligand, a linker, and a chelator—enabling binding to the radionuclide technetium-99m via the chelator and targeting carbonic anhydrase IX (CAIX) enzyme receptors through its organic ligand. Given the promising results from preclinical and Phase I clinical studies, this radiopharmaceutical is an encouraging SPECT tracer for the future, with the potential to detect primary and metastatic lesions of ccRCC in various anatomical locations.

Theranostic and Therapeutic Products

• Production, Quality Control, and Radiolabeling of NM-600with ⁶⁸Ga, ¹⁷⁷Lu, and ⁹⁰Y      

Triple-negative breast cancer (TNBC) refers to any breast cancer that lacks estrogen receptor (ER), progesterone receptor (PR), and HER2 expression. Approximately 10–15% of breast cancers in women are TNBC. Treating this type of cancer is more challenging, as most hormonal therapies target one of these three receptors. NM600, due to its tumor-targeting properties and efficacy in malignant T-cells, provides an excellent therapeutic window in both localized and metastatic models of the disease, with no associated toxicity. The interaction of targeted radionuclide therapy (TRT) with the innate immune system to achieve a high response rate demonstrates the successful application of TRT for treating TNBC and T-cell non-Hodgkin lymphoma (NHL).

 

• Production, Quality Control, and Labeling of FAPI-2972 with ⁶⁸Ga and ¹⁷⁷Lu

This radiopharmaceutical can significantly contribute to the diagnosis and treatment of over 30 types of cancer, benefiting the country’s medical community. Key beneficiaries of this project include academic research centers in nuclear pharmacy, nuclear medicine research centers, nuclear medical centers, and hospitals.

 

• Production and optimization of the therapeutic protocol for the radiopharmaceutical Pentixather

Multiple myeloma is a cancer that develops in a type of white blood cell called a plasma cell. In multiple myeloma, cancerous plasma cells accumulate in the bone marrow and destroy healthy blood cells. Instead of producing beneficial antibodies, these cancerous cells generate abnormal proteins, which can lead to complications.

First, the radiopharmaceutical ⁶⁸Ga-Pentixafor is used for disease detection and tracking, followed by the therapeutic radiopharmaceutical ¹⁷⁷Lu-Pentixather for adjuvant treatment. Finally, after bone marrow destruction, the patient will be prepared for a bone marrow transplant.

 

• Production, quality control, and labeling of DOTATATE and PSMA with ²²⁵Ac

Treatment of therapy-resistant prostate cancers and neuroendocrine tumors using alpha-emitting radioisotopes.

 

• Production and quality control of the radiopharmaceutical ¹⁷⁷Lu-DOTA-PEG₄-LLP2A7
  Diagnosis and treatment of melanoma

 

• Production, Quality Control, and Clinical Evaluation of the Radiopharmaceuticals ⁶⁸Ga-DOTA-LM3and ¹⁷⁷Lu-DOTA-LM3

Peptide Receptor Radionuclide Therapy (PRRT) using somatostatin analogs has long been an advanced and common method in nuclear medicine. This approach targets the tumor microenvironment of neuroendocrine tumors (NETs). The outer membrane of cancer cells contains significant amounts of somatostatin receptors or their derivatives, which serve as therapeutic targets in this method.

 

• Production, Quality Control and Clinical Evaluation of the Radiopharmaceutical ²²⁵Ac-FAPI

Treatment of a wide range of therapy-resistant cancers

 

• Production, Quality Control and Clinical Evaluation of Radiopharmaceuticals ⁶⁸Ga-αMSH, ²²⁵Ac-αMSH, and ¹⁷⁷Lu-αMSH

Diagnosis and treatment of melanoma

 

• Production, Quality Control and Clinical Evaluation of the Radiopharmaceutical Radium-223 (²²³Ra)

For treatment of patients with castration-resistant prostate cancer (CRPC) with bone metastases

 

• Combined therapy using ¹⁷⁷Lu-FAPI with chemotherapy, immunotherapy, and hormone therapy

Enhancing treatment efficacy for a wide range of cancers

 

• Production and Quality Control of radiolabeled neuropeptide ligands for theranostic purposes in cancer patients

Diagnosis and treatment of a wide range of gastrointestinal cancers

 

• Preparation and completion of preclinical studies for the therapeutic radiopharmaceutical ¹⁷⁷Lu-Rorstatin

Targeted therapy for breast cancer

 

• Production of brachytherapy iodine-125 (¹²⁵I) sources

Brachytherapy, as a method of irradiating cancerous tissues, is a highly effective treatment for various cancers, including brain tumors, ocular tumors, prostate cancer, and more. The unique and remarkable outcomes of this technique compared to other treatment modalities have led to its growing recognition in nuclear medicine. Iran is no exception to this trend, and the absence of this therapeutic technology is acutely felt. As the sole producer of radioactive sources in the country, Pars Isotope Company is committed to addressing the needs of nuclear medicine centers in this field.