Advancing novel molecular imaging agents from preclinical studies to first-in-humans phase I clinical trials in academia--a roadmap for overcoming perceived barriers

Bioconjugate Chemistry
Raymond M ReillyMark Levine

Abstract

There is a critical need to advance promising novel molecular imaging (MI) agents for cancer from preclinical studies to first-in-humans Phase I clinical trials in order to realize their full potential for cancer detection and for predicting or monitoring response to targeted ("personalized") cancer therapies. Steps to clinical translation include radiopharmaceutical formulation, preclinical pharmacology and toxicology studies, clinical trial design and human ethics approval, and regulatory agency submission. In this Topical Review, we provide a "roadmap" to advancing one class of novel MI agents to Phase I trials in academia and illustrate the processes that we have successfully applied for (111)In-labeled pertuzumab, a MI probe for monitoring response of HER2-positive breast cancer to treatment with trastuzumab (Herceptin). We hope that our experience will encourage other academic radiopharmaceutical scientists to embrace this challenge.

References

Aug 28, 2001·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J Baselga, J Albanell
Oct 26, 2005·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Michael J MorrisHoward I Scher
Feb 17, 2006·Investigative Radiology·Adrian D Nunn
May 20, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Patrick J PerikElisabeth G E de Vries
Mar 7, 2007·Clinical Pharmacology and Therapeutics·K McLarty, R M Reilly
Jun 5, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Andrew M ScottLloyd J Old
May 6, 2009·The AAPS Journal·Eric D Agdeppa, Mary E Spilker
May 16, 2009·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Eli C F DijkersMarjolijn N Lub-de Hooge
Jul 21, 2009·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Kristin McLartyRaymond M Reilly
Oct 20, 2009·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Kristin McLartyRaymond M Reilly
Oct 5, 2013·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Geraldine GebhartSerena Di Cosimo
Dec 18, 2013·Nuclear Medicine Communications·Zareth Ortiz-ArzateVanessa Izquierdo-Sánchez
Mar 26, 2014·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Jens SörensenHenrik Lindman
Apr 16, 2014·Molecular Imaging and Biology : MIB : the Official Publication of the Academy of Molecular Imaging·Sherly MosessianMichael E Phelps
Jun 11, 2014·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Sally W SchwarzJohn M Hoffman
Dec 3, 2014·Applied Radiation and Isotopes : Including Data, Instrumentation and Methods for Use in Agriculture, Industry and Medicine·Karen LamRaymond M Reilly

❮ Previous
Next ❯

Citations

Jan 31, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Dariusz PawlakClemens Decristoforo
Sep 30, 2015·Oncotarget·Xing YangMartin G Pomper

❮ Previous
Next ❯

Related Concepts

Related Feeds

Breast Cancer: Therapeutic Approaches

Several different therapeutic approaches are used to treat breast cancer. These include chemotherapy, hormonal therapy, targeted therapy, and Immunotherapy. Discover the latest research on breast cancer therapeutic approaches here.

Related Papers

CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne
Sally Murray
Applied Radiation and Isotopes : Including Data, Instrumentation and Methods for Use in Agriculture, Industry and Medicine
Karen LamRaymond M Reilly
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Susan E Bates
Nihon rinsho. Japanese journal of clinical medicine
Hiroyasu Yamashiro, Masakazu Toi
© 2021 Meta ULC. All rights reserved