Comprehensive Cancer Center (CCC) Radiolabeling/Imaging/Dosimetry Shared Facility (RIDSF)

Director: Ahmad Safavy, PhD

Department/Center Association: CCC

Established: 1994

Mission

The Radiolabeling/Imaging/Dosimetry Shared Facility (RIDSF) was established to provide radiolabeling services for in vitro laboratory studies, in vivo animal model investigations, and in vivo human clinical protocols. The Facility has extensive experience with radiolabeling procedures for a wide range of radioactive isotopes and provides appropriate quality control procedures to ensure standardized and high-quality reagents to Comprehensive Cancer Center (CCC) members. The primary objective of the RIDSF is to provide high-quality radiolabeled reagents for in vitro studies and for in vivo use in animals and humans.

Research Information

The RIDSF has been a major component of this Cancer Center’s research efforts in targeted immunotherapy. It has provided research faculty from tumor immunology, experimental therapeutics, women’s cancer and more recently neuron-oncology disciplines with quality radiolabeled reagents for pre-clinical and clinical investigations. It has experience with radiolabeling antibodies, fusion proteins, peptides and other molecules using a wide range of radioisotopes. It also has significant experience with preparation of human use radiolabeled reagents for clinical trials which have utilized ⁹⁰Y, ¹²⁵I, ¹³¹I, ¹¹¹In, ¹⁷⁷Lu, ¹⁸⁶Re, and ¹⁸⁸Re. These studies have progressed from radiolabeled murine monoclonal antibodies, to genetically engineered humanized reagents and more recently the use of novel fusion proteins in pretargeting format. The Facility has supported over 25 clinical trials resulting in over 45 publications and an equal number of publications on preclinical studies.

The presence of this high quality radiolabeling facility and research gamma camera has been a major factor in allowing our Cancer Center to take the lead in developing new radioimmunotherapy paradigms over the current funding period including:

• Development of Zevalin (FDA approval for follicular lymphoma) and supporting UAB-led trials to optimize its use.
• Use of a novel ¹³¹I-labeled chlorotoxin (peptide) for intracavitary delivery in resected recurrent glioblastoma multiforme.
• Use of a genetically engineered humanized antibody (CC49) with a deleted CH2 region to provide a novel targeting molecule with low immunogenicity and short plasma half-life. These studies include ¹³¹I-CC49∆CH2 I.V. for GI malignancies and I.P. in ovarian cancer as well as a conjugated form of the molecule for ^IIIIn/⁹⁰Y trials.
• Use of a novel fusion protein composed of four single chain antibodies and the four chains of streptavidin as the targeting moiety in pretargeting radioimmunotherapy. We have completed initial phase-I trials in lymphoma (anti CD20) and GI cancer (anti TAG72) and await reagents for further phase I/II trials.

Thus, the Facility is vitally important to one of the major translational research efforts of the Cancer Center with involvement of faculty from multiple programs and SPORES.

Further, the coordination of isotope receipt with waste disposal in the Wallace Tumor Institute is a major responsibility of the Cancer Center in support of the various research faculty based in this building.

Services and Fees

The Facility generates radiolabeled reagents for human use including safety-oriented procedures for large doses of therapeutic radioactive investigational agents. The expansion of its capabilities, including the purchase of an AXIS (Picker International/Marconi) dual-head camera imaging system in 2001, provides high quality imaging and dosimetry estimate analysis for the protocols in our immunotherapy program. The development of these additional capabilities has allowed the Facility to play an important role in translational research and targeted immunotherapy efforts. Services for CCC members include consultation related to radiolabeling of proteins, peptides, and oligonucleotides. In addition, centralized purchasing of isotopes leads to a very cost-effective utilization of research funds. The Facility is also responsible for radiation waste management in the Wallace Tumor Institute including acquisition, utilization, and documentation of waste generation and disposal. It provides documentation of all radiolabeled reagents for human use according to FDA, state, and other regulatory agencies. The RIDSF is the CCC’s interface with the Radiation Safety Department and Waste Management group of UAB.

Specific services provided by the Facility include:

· Radiolabeled reagents for in vitro studies, which have rigorous quality control regarding degree of isotope binding and reactivity.

· Radiolabeled reagents for in vivo animal experimentation, which have appropriate analysis for purity, specificity, and structural integrity.

· Radiolabeled reagents for in vivo human use, which fulfill guidelines of the UAB Radioisotope Committee and the FDA.

· Consultation to CCC investigators regarding radiolabeling technology and custom-made radiolabeling procedures.

· Coordination of the radioactive waste management in the Wallace Tumor Institute in regard to interface with the Radiation Safety Department and Waste Management.

· Provision of high quality imaging and dosimetry estimate analysis for clinical trials of radioimmunotherapy.

Contact Information

Director: Ahmad Safavy, PhD

Email: safavy@uab.edu

Phone: 205-934-3681

Web site: http://www3.ccc.uab.edu/show.asp?durki=59564

Approved by: Ahmad Safavy, PhD, Director

Date: February 25, 2008

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