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New Imaging Agent to Drive Step-Change for Brain Cancer Imaging

By MedImaging International staff writers
Posted on 07 Nov 2024
Image: The Pixclara PET imaging agent for glioma could provide patients with greater diagnostic clarity (Photo courtesy of Telix)
Image: The Pixclara PET imaging agent for glioma could provide patients with greater diagnostic clarity (Photo courtesy of Telix)

Gliomas are highly diffusely infiltrative tumors that impact the surrounding brain tissue. They represent the most prevalent type of central nervous system (CNS) neoplasm originating from glial cells, accounting for around 30% of all brain and CNS tumors and approximately 80% of malignant brain tumors. There is a significant unmet need to enhance the diagnosis and management of gliomas, particularly after treatment. Traditional MRI imaging techniques have various limitations, such as a lack of biological specificity, reliance on the disruption of the blood-brain barrier, and an intrinsic inability to distinguish between tumor progression and treatment-related changes. These issues can lead to inconclusive results, delaying critical treatment decisions. With low survival rates and the necessity for prompt actions, precision imaging becomes essential. Now, a new PET imaging agent for gliomas has the potential to meet this need, providing patients with clearer diagnoses and aiding treatment decision-making.

Telix Pharmaceuticals (Melbourne, Australia) has developed Pixclara (18F-floretyrosine or 18F-FET), a PET agent designed to differentiate between progressive or recurrent gliomas and treatment-related changes in both adult and pediatric patients. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara), an imaging agent for gliomas. This application has been given priority review status, with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2025, facilitating a potential U.S. commercial launch in 2025.

While FET PET is already part of international clinical practice guidelines for glioma imaging, there is currently no FDA-approved targeted amino acid PET agent available for adult and pediatric brain cancer imaging in the U.S. Given its potential to fulfill a significant medical need, Pixclara has been designated as an orphan drug and granted fast track designation by the FDA. Telix is also exploring the possibility of using Pixclara as a companion diagnostic agent for TLX101-Tx, an investigational neuro-oncology drug in development that targets the same amino acid transporter mechanism with therapeutic radiation.

“Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S., and bring it into line with a more advanced standard of care currently used in other markets,” said Kevin Richardson, Chief Executive Officer, Telix Precision Medicine. “There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.”

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98 (!!!!! 1787.1856689453): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
99 (76.055526733398): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
100 (50.067901611328): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
101 (41.961669921875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
102 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
103 (38.862228393555): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
104 (72.002410888672): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
105 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
106 (392.91381835938): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
107 (!!!!! 39891.004562378): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
108 (!!!!! 2044.9161529541): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294802995 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294802995 AND type='deeppockets_item' AND published='1' LIMIT 1
109 (!!!!! 13593.912124634): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
110 (46.014785766602): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
111 (468.96934509277): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
112 (38.862228393555): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
113 (550.0316619873): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
114 (35.04753112793): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
115 (277.04238891602): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
116 (32.901763916016): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
117 (318.05038452148): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
118 (549.7932434082): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
119 (257.01522827148): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
120 (128.98445129395): SELECT name FROM jos_deeppockets WHERE id=213
121 (31.948089599609): SELECT name FROM jos_deeppockets WHERE id=213
122 (798.94065856934): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
123 (483.03604125977): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
124 (!!!!! 5208.9691162109): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
125 (63.896179199219): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
126 (!!!!! 13056.039810181): TRUNCATE TABLE jos_trademed_module
127 (!!!!! 1943.826675415): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294802995 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
128 (787.01972961426): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
129 (!!!!! 2232.0747375488): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
130 (859.97581481934): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
131 (53.882598876953): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
132 (!!!!! 2449.0356445312): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
133 (928.16352844238): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
134 (53.882598876953): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
135 (464.91622924805): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294802995 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294802995 AND type='deeppockets_item' AND published='1' LIMIT 1
136 (489.95018005371): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
137 (37.908554077148): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
138 (127.07710266113): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
139 (!!!!! 1832.0083618164): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
140 (58.889389038086): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294802995 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294802995 AND published='1' LIMIT 1
141 (195.02639770508): select jos_twitters.link from jos_twitters where cat=10
142 (31.948089599609): select jos_facebook.link from jos_facebook where cat=10
143 (29.087066650391): select jos_google_plus.link from jos_google_plus where cat=10
144 (606.06002807617): select jos_linkedin.link from jos_linkedin where cat=10
145 (753.87954711914): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
146 (!!!!! 1188.0397796631): insert into jos_banners_delta values (14615,'2025-06-21 00:46:55','216.73.216.120','view'),(14202,'2025-06-21 00:46:55','216.73.216.120','view'),(14203,'2025-06-21 00:46:55','216.73.216.120','view')