Technetium Tc 99m trofolastat(Technetium Tc 99m trofolastat) - 药物靶点：PSMA_在研适应症：前列腺癌_专利_临床

概要

基本信息

药物类型

诊断用放射药物、核素偶联药物

别名

99mTc-trofolastat、Technetium Tc 99M Trofolastat Chloride

+ [5]

靶点

PSMA

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)、SPECT(单光子发射计算机断层成像术增强剂)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

前列腺癌

非在研适应症

造影剂先天性甲肥厚

原研机构

Progenics Pharmaceuticals, Inc.

在研机构

PDRadiopharma, Inc.Lantheus Medical Imaging, Inc.

非在研机构

Progenics Pharmaceuticals, Inc.

FUJIFILM Toyama Chemical Co., Ltd.

Molecular Insight Pharmaceuticals, Inc.

+ [1]

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C40H42N10O23Tc

InChIKeySEMUBPUAWVZHAS-INZTZQCYSA-F

CAS号1333204-77-5

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关联

14

项与 Technetium Tc 99m trofolastat 相关的临床试验

EUCTR2021-001059-15-SE / Unknown status临床2期IIT

The value of 99mTc-MIP-1404 SPECT/CT Veriton CZT for staging ofprostate cancer and before primary therapy and in biochemical recurrenceafter radical prostatectomy. Fase II study.

开始日期2022-04-05

申办/合作机构-

EUCTR2021-000486-33-FI / Unknown status临床3期IIT

99mTc-MIP-1404 SPECT/CT for primary PROstate cancer STAging: comparative prospective, randomized trial to present guideline imaging

开始日期2022-03-21

申办/合作机构

Turku University Hospital

JPRN-jRCT2080223135 / Completed临床2期

Phase IIb Study of F-1311 in Patients with Prostate Cancer

开始日期2016-05-24

申办/合作机构

PDRadiopharma, Inc.

100 项与 Technetium Tc 99m trofolastat 相关的临床结果

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100 项与 Technetium Tc 99m trofolastat 相关的转化医学

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100 项与 Technetium Tc 99m trofolastat 相关的专利（医药）

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11

项与 Technetium Tc 99m trofolastat 相关的文献（医药）

2023-02-01·Journal of Nuclear Medicine

Eligibility for¹⁷⁷Lu-PSMA Therapy Depends on the Choice of Companion Diagnostic Tracer: A Comparison of⁶⁸Ga-PSMA-11 and^99mTc-MIP-1404 in Metastatic Castration-Resistant Prostate Cancer

Article

作者: Leaning, Darren ; Cook, Gary J R ; Wong, Wai-Lup ; Mangar, Stephen ; Challapalli, Amarnath ; Bassett, Paul ; Bahl, Amit ; Schmidkonz, Christian ; Sanghera, Bal

¹⁷⁷Lu-prostate-specific membrane antigen-617 (¹⁷⁷Lu-PSMA-617) is an effective therapy for metastatic castration-resistant prostate cancer (mCRPC), with evidence of improved survival over standard care. The VISION trial inclusion criteria required a metastatic lesion-to-liver ratio of greater than 1 on ⁶⁸Ga-PSMA-11 PET scans. We aimed to determine whether an equivalent ratio is suitable for a SPECT tracer, ^99mTc-MIP-1404, and to compare lesion and lesion-to-normal-organ ratios between the 2 radiotracers. Methods: Two cohorts of patients with mCRPC matched for age, prostate-specific antigen level, and total Gleason score, with either ^99mTc-MIP-1404 SPECT/CT (n = 25) or ⁶⁸Ga-PSMA-11 PET/CT (n = 25) scans, were included for analysis. Up to 3 lesions in each site (prostate/prostate bed, lymph nodes, bone and soft-tissue metastases) as well as normal liver, parotid gland, spleen, and mediastinal blood-pool SUV_max were measured. Results: ^99mTc-MIP-1404 SPECT lesion SUV_max was not significantly different from ⁶⁸Ga-PSMA-11 PET (median, 18.2 vs. 17.3; P = 0.93). However, ^99mTc-MIP-1404 liver SUV_max was higher (median, 8.5 vs. 5.8; P = 0.002) and lesion-to-liver ratios were lower (median, 2.7 vs. 3.5; P = 0.009). There was no significant difference in parotid gland or splenic SUV_max or lesion-to-parotid gland ratios between the 2 tracers although there was a small difference in lesion-to-spleen ratios (P = 0.034). Conclusion: There are differences in biodistribution and, in particular, liver activity, between ⁶⁸Ga-PSMA-11 and ^99mTc-MIP-1404. Therefore, if ^99mTc-MIP-1404 is used to assess eligibility for ¹⁷⁷Lu-PSMA-617 therapy, a lower adjusted lesion-to-liver ratio should be used.

2023-01-01·Journal of Nuclear Medicine

Feasibility of^99mTc-MIP-1404 for SPECT/CT Imaging and Subsequent PSMA-Radioguided Surgery in Early Biochemically Recurrent Prostate Cancer: A Case Series of 9 Patients

Article

作者: Apostolova, Ivayla ; Koehler, Daniel ; Klutmann, Susanne ; Maurer, Tobias ; Lehnert, Wencke ; Sauer, Markus ; Knipper, Sophie ; Budäus, Lars

This case series evaluated the feasibility of prostate-specific membrane antigen (PSMA)-radioguided surgery (RGS) with ^99mTc-MIP-1404 in recurrent prostate cancer. Methods: Nine patients with PSMA-positive lesions on PET/CT received ^99mTc-MIP-1404 (median, 747 MBq; interquartile range [IQR], 710-764 MBq) 17.2 h (IQR, 16.9-17.5 h) before SPECT/CT and 22.3 h (IQR, 20.8-24.0 h) before RGS. Results: Seventeen PSMA-positive lesions were detected on PET/CT (median short-axis diameter, 4 mm; IQR, 3-6 mm; median SUV_max, 8.9; IQR, 5.2-12.6). Nine of 17 (52.9%) were visible on SPECT/CT (median SUV_max, 13.8; IQR, 8.0-17.9). Except for 2 foci, all PET/CT-positive findings demonstrated intraoperative count rates above the background level (median count, 31; IQR, 17-89) and were lymph node metastases. Moreover, PSMA-RGS identified 2 additional metastases compared with PET/CT. Prostate-specific antigen values decreased after RGS in 6 of 9 patients (67%). Conclusion: PSMA-RGS with ^99mTc-MIP-1404 identified lymph node metastases in all patients, including 2 additional lesions compared with PET/CT.

2019-12-01·Annals of Nuclear Medicine

PSMA SPECT/CT with 99mTc-MIP-1404 in biochemical recurrence of prostate cancer: predictive factors and efficacy for the detection of PSMA-positive lesions at low and very-low PSA levels

Article

作者: Kuwert, Torsten ; Schmidkonz, Christian ; Prante, Olaf ; Cordes, Michael ; Ritt, Philipp ; Bäuerle, Tobias ; Goebell, Peter ; Goetz, Theresa Ida

BACKGROUNDThe in vivo expression of the prostate-specific membrane antigen (PSMA) can be investigated using the SPECT-suitable tracer ^99mTc-MIP-1404. We investigated the performance of ^99mTc-MIP-1404 PSMA SPECT/CT in the detection of PSMA-positive tumor lesions in patients suffering from biochemical recurrence of prostate cancer presenting with serum levels of the prostate-specific antigen (PSA) below 1 ng/mL.METHODSWe retrospectively analyzed ^99mTc-MIP-1404-SPECT/CT scans of 50 patients (25 with low PSA levels between > 0.5 and 1 ng/mL and 25 with very low PSA levels between 0.2 and 0.5 ng/mL) that had undergone whole-body planar scintigraphy and SPECT/CT of the thorax, abdomen and pelvis 3-4 h p.i. of 691 ± 72 MBq ^99mTc-MIP-1404. All datasets were evaluated for the presence and location of PSMA-positive tumor lesions, in which maximal standardized uptake values (SUV_max) were also measured. Based on the results of the quantitative evaluation as well as on biochemical and histological parameters, predictive factors for a positive ^99mTc-MIP-1404 scan result were determined. The influence of ^99mTc-MIP-1404 PSMA SPECT/CT on further therapy planning was assessed, based on the decision-making of the interdisciplinary tumor board.RESULTSPathological ^99mTc-MIP-1404 uptake was detected in a total of 25 patients (50%). In the very low PSA subgroup, detection rates of PSMA-positive lesions suggestive of tumor recurrence were 44%, in the low-PSA subgroup 56%. Gleason scores ≥ 8 and the presence of antiandrogen deprivation therapy were further significant predictors of pathological ^99mTc-MIP-1404 uptake. This was paralleled by significantly higher lesional SUV_max patients with PSA levels > 0.5 ng/mL and Gleason scores ≥ 8 compared to those without these two features. Changes in therapeutic strategy following MIP-1404 imaging were recommended by the interdisciplinary tumor board in 25/50 of patients.CONCLUSION^99mTc-MIP-1404 PSMA-SPECT/CT demonstrated a high performance in detecting PSMA-positive lesions suggestive of tumor recurrence in patients with biochemical recurrence of prostate cancer and low and very low serum PSA levels. Results from MIP-1404 PSMA SPECT/CT have therapeutic impact in one-half of the patients examined by this technology.

100 项与 Technetium Tc 99m trofolastat 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
前列腺癌	临床3期	美国	Lantheus Medical Imaging, Inc.	-
先天性甲肥厚	临床2期	捷克	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
先天性甲肥厚	临床2期	意大利	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
先天性甲肥厚	临床2期	匈牙利	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
先天性甲肥厚	临床2期	美国	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
先天性甲肥厚	临床2期	俄罗斯	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
先天性甲肥厚	临床2期	荷兰	Molecular Insight Pharmaceuticals, Inc.	2012-08-01
造影剂	临床2期	-	FUJIFILM Corp.	-
造影剂	临床2期	-	Progenics Pharmaceuticals, Inc.	-
先天性甲肥厚	药物发现	比利时	Molecular Insight Pharmaceuticals, Inc.	2012-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2019	N/A	前列腺癌	-	99mTc-MIP-140499m Tc-MIP-1404 (99mTc-MIP-1404)	壓衊鏇艱廠獵鹽壓廠選(廠糧願廠願糧淵構網積) = 憲窪觸夢蓋襯鹽選艱餘醖鏇鑰鹽鬱顧艱製餘衊 (鏇觸觸艱淵夢遞選糧憲, 0.23) 更多	-	2019-05-21
SNMMI2018	N/A	前列腺癌	-	99m Tc-MIP-140499mTc-MIP-14044 (99mTc-MIP-1404 SPECT/CT)	膚餘糧衊膚餘夢窪鑰鑰(糧鑰膚艱獵襯淵鑰獵淵) = TUprostate is correlated with Gleason score and PSA serum concentration and allows prediction of the occurrence of lymph node and bone metastases with moderate accuracy at primary staging 鏇選鹹憲觸鹽衊築遞鏇 (構廠構簾醖積壓築構鏇 )	-	2018-05-23
NCT01667536 (Pubmed \| J Nucl Med) 人工标引	临床2期	前列腺癌	105	99m Tc-Trofolastat	(積選構選鬱衊糧壓廠壓) = 夢積淵蓋鏇鏇齋鏇膚憲糧醖鬱糧築壓簾簾鹽醖 (齋範艱膚餘製餘積遞膚 ) 更多	积极	2017-09-01
NCT01667536 (CTgov)	临床2期	先天性甲肥厚 \| 前列腺癌	105	Drug: 99mTc-MIP-1404	築積選鏇衊獵築獵夢糧(艱鏇獵鏇膚築鏇廠淵遞) = 醖築窪糧願範觸窪鏇築鹽壓範壓窪淵構獵膚襯 (廠築壓鬱淵艱築醖壓膚, 糧襯構選鏇蓋願獵醖築 ~ 糧齋鏇襯網遞淵鑰醖網) 更多	-	2016-03-30