Nuclear Pharmacy Core

As one of the nation’s few academic research nuclear pharmacies with access to an onsite cyclotron, our nuclear pharmacy collaborates with physicians and researchers from various specialties such as oncology, cardiology, urology, and neurology to safely compound, prepare and dispense sterile radiopharmaceuticals for patient-specific diagnostic imaging scan or therapeutic treatment. The nuclear pharmacy coordinates with the cyclotron for radiopharmaceutical manufacturing and the Positron Emission Tomography (PET) Imaging Core for in-house diagnostic imaging providing translation of novel radiotracers into clinical practice.

Core Director:

Richard Le, PhD
rle@houstonmethodist.org

Radiopharmaceuticals

FDA Approved for Hospital Clinical Use

1. [18F] Fludeoxyglucose (Oncology) 
2. [68Ga] Netspot (Oncology)
3. [68Ga] Illuccix (Urology)
4. [68Ga] DOTATOC (Oncology)*
5. [68Ga] PSMA (Urology)*
6. [13N]- Ammonia (Cardiology) 

*Pending FDA ANDA approval

FDA Approved for Research/Investigational Use

1. [11C] ER176 (Neurology)
2. [11C] PiB (Neurology)
3. [11C] PBR28 (Neurology)
4. [18F] FAV-1451 (Neurology) 
5. Various proprietary radiotracers in different clinical trial phases for cardiology, oncology, and neurology

Nuclear Pharmacy Services

1. Authorized Nuclear Pharmacists and Technicians will compound, prepare, and dispense FDA approved clinical and investigational radiopharmaceuticals 
2. Review clinical trial drug study protocols for site initiation
3. Assess drug safety (pharmacovigilance) profile
4. Advise on facility design for implementation of radiotherapeutic drugs
5. Provide expertise on United States Pharmacopeia (USP) 825 compliance of radiopharmaceuticals
6. Establish environmental monitoring program for maintaining sterile processes
7. Perform acceptable quality control set forth by USP Monographs or Manufacturer’s specifications
8. Distribution of internal and external radiopharmaceuticals

Equipment

1. USP 825 and State Board of Pharmacy compliant nuclear pharmacy facility with aseptic ISO 5 dispensing hot cell and telemanipulators for radiopharmaceutical dispensing
2. USP 797 compliant dedicated ISO 5 clean room for nonradioactive aseptic preparations and manufacturing processes