This early phase I trial tests the use of a radioactive tracer (a drug that is visible during an imaging test) known as 18F-FMAU, for imaging with positron emission tomography/computed tomography (PET/CT) in patients with brain cancer or cancer that has spread to the brain (brain metastases). A PET/CT scan is an imaging test that uses a small amount of radioactive tracer (given through the vein) to take detailed pictures of areas inside the body where the tracer is taken up. 18F-FMAU may also help find the cancer and how far the disease has spread. Magnetic resonance imaging (MRI) is a type of imaging test used to diagnose brain tumors. 18F-FMAU PET/CT in addition to MRI may make the finding and diagnosing of brain tumor easier.

Start Date15 Feb 2021

Sponsor / Collaborator

University of Southern California

[+1]

NCT02809690 / TerminatedPhase 1IIT

Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer

This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that is given through the vein to take detailed pictures of areas inside the body where the tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the disease has spread.

Start Date12 Sep 2016

Sponsor / Collaborator

University of Southern California

[+2]

100 Clinical Results associated with 18F-FMAU

100 Translational Medicine associated with 18F-FMAU

100 Patents (Medical) associated with 18F-FMAU

Literatures (Medical) associated with 18F-FMAU

01 Feb 2017·Molecular Imaging and BiologyQ3 · MEDICINE

Comparative Analysis of Human Nucleoside Kinase-Based Reporter Systems for PET Imaging

Q3 · MEDICINE

Article

Author: van Dam, R Michael ; Ponomarev, Vladimir ; Likar, Yury ; Moroz, Maxim A ; Zhang, Hanwen ; Collins, Jeffrey ; Shenker, Larissa ; Lee, Jason T ; Zurita, Juan ; Lobo, Jose ; Sumzin, Nikita

PURPOSERadionuclide-based reporter gene imaging has the sensitivity to monitor gene- and cell-based therapies in human subjects. Potential immunogenicity of current viral transgenes warrants development of human-based reporter systems. We compared human nucleoside kinase reporters to a panel of nucleoside analogs of FEAU, FMAU, and FIAU, including the first in vivo assessment of L-[¹⁸F]FEAU.PROCEDURESHuman isogenic U87 cell lines were transduced to express different human reporter genes including dCK-R104M/D133A (dCKDM), dCK-R104Q/D133N (dCKep16A), dCK-A100V/R104M/D133A (dCK3M), and TK2-N93D/L109F (TK2DM), and wild-type dCK (dCK) and herpes simplex virus type-1 (HSVTK) reporter gene as references. In vitro cell uptake assays were performed with [¹⁸F]FEAU, L-[¹⁸F]FEAU, [¹⁴C]FMAU, L-[¹⁸F]FMAU, and [¹²⁴I]FIAU. Micro-positron emission tomography/X-ray computed tomography imaging of xenograft-bearing nu/nu mice was conducted with [¹⁸F]FEAU, L-[¹⁸F]FEAU, L-[¹⁸F]FMAU, and [¹²⁴I]FIAU on consecutive days. A cell viability assay was also performed to assess sensitivities to gemcitabine and bromovinyldeoxyuridine (BVdU).RESULTSIn vitro, dCKep16A and dCKDM with [¹⁸F]FEAU exhibited the highest sensitivity and selectivity of the human reporters, second only to HSVTK/[¹⁸F]FEAU. L-[¹⁸F]FEAU biodistribution in mice was on par with [¹⁸F]FEAU and L-[¹⁸F]FMAU. L-[¹⁸F]FMAU uptake in isogenic xenografts was highest for all human reporter genes. However, [¹⁸F]FEAU was the most selective of the short half-life reporter probes due to its minimal recognition by human dCK and relative sensitivity, whereas [¹²⁴I]FIAU permitted imaging at a later time point, improving signal-to-background ratio. Of the human reporter genes, dCKep16A consistently outperformed the other tested reporters. Reporter genes of interest increased potency to the nucleoside analog prodrugs gemcitabine and BVdU.CONCLUSIONSWe demonstrate that human nucleoside kinase reporter systems vary significantly in their sensitivity and selectivity for in vivo imaging. The sufficiently high signal-to-background ratios and enhanced suicide gene potential support clinical translation.

100 Deals associated with 18F-FMAU

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Brain metastases	Phase 1	US	National Cancer Institute	15 Feb 2021
Colonic Cancer	Phase 1	US	National Cancer Institute	15 Feb 2021
Glioma	Phase 1	US	National Cancer Institute	15 Feb 2021
Melanoma, Cutaneous Malignant	Phase 1	US	National Cancer Institute	15 Feb 2021
Metastatic breast cancer	Phase 1	US	National Cancer Institute	15 Feb 2021
Metastatic Colorectal Carcinoma	Phase 1	US	National Cancer Institute	15 Feb 2021
Metastatic Lung Cancer	Phase 1	US	National Cancer Institute	15 Feb 2021
Metastatic melanoma	Phase 1	US	National Cancer Institute	15 Feb 2021
Renal Cell Carcinoma	Phase 1	US	National Cancer Institute	15 Feb 2021
Prostatic Cancer	Phase 1	-	The University of Texas at Austin	-

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