Delving into the Latest Updates on Technetium Tc 99m trofolastat with Synapse

Overview

Basic Info

Drug Type

Diagnostic radiopharmaceuticals, Radionuclide Drug Conjugates (RDC)

Synonyms

99mTc-trofolastat, Technetium Tc 99M Trofolastat Chloride

+ [5]

Target

PSMA

Mechanism

PSMA inhibitors(Prostate-specific membrane antigen inhibitors), SPECT(Single-photon emission-computed tomography enhancers)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Prostatic Cancer

Inactive Indication

Contrast agentsPachyonychia Congenita

Originator Organization

Progenics Pharmaceuticals, Inc.

Active Organization

PDRadiopharma, Inc.Lantheus Medical Imaging, Inc.

Inactive Organization

Progenics Pharmaceuticals, Inc.

FUJIFILM Toyama Chemical Co., Ltd.

Molecular Insight Pharmaceuticals, Inc.

+ [1]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure

Molecular FormulaC40H42N10O23Tc

InChIKeySEMUBPUAWVZHAS-INZTZQCYSA-F

CAS Registry1333204-77-5

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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.

01 Jan 2023·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

Author: 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.

01 Dec 2019·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

Author: 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 Deals associated with Technetium Tc 99m trofolastat

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	US	Lantheus Medical Imaging, Inc.	-
Pachyonychia Congenita	Phase 2	CZ	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Pachyonychia Congenita	Phase 2	IT	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Pachyonychia Congenita	Phase 2	HU	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Pachyonychia Congenita	Phase 2	US	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Pachyonychia Congenita	Phase 2	RU	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Pachyonychia Congenita	Phase 2	NL	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012
Contrast agents	Phase 2	-	FUJIFILM Corp.	-
Contrast agents	Phase 2	-	Progenics Pharmaceuticals, Inc.	-
Pachyonychia Congenita	Discovery	BE	Molecular Insight Pharmaceuticals, Inc.	01 Aug 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2019	Not Applicable	Prostatic Cancer	-	99mTc-MIP-140499m Tc-MIP-1404 (99mTc-MIP-1404)	inoaintoit(txceyjfeke) = udfkppwhno ouwcgnrfdc (qasuofnhwj, 0.23) View more	-	21 May 2019
SNMMI2018	Not Applicable	Prostatic Cancer	-	99m Tc-MIP-140499mTc-MIP-14044 (99mTc-MIP-1404 SPECT/CT)	kenpsaedre(efseayfjto) = 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 imjnueevvs (dmpziaxdgq )	-	23 May 2018
NCT01667536 (Pubmed \| J Nucl Med) Manual	Phase 2	Prostatic Cancer	105	99m Tc-Trofolastat	(rzsprvqbap) = qbzxqycbux qvaatwzwvs (tqqrfgyege ) View more	Positive	01 Sep 2017
NCT01667536 (CTgov)	Phase 2	Pachyonychia Congenita \| Prostatic Cancer	105	Drug: 99mTc-MIP-1404	ppfuulxkoi(cpankeiboc) = gaexujnkdh pbazkfvlsv (frflulpvpe, ijahvducwo - qjaimxloru) View more	-	30 Mar 2016