Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06219746
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-11-03
Brief Title:
99mTc-MIP-1404 SPECTCT in Primary Staging of Prostate Cancer
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
99mTc-MIP-1404 SPECTCT for Primary PROstate Cancer STAging Comparative Prospective Randomized Trial to Present Guideline Imaging
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prostate cancer PCa is currently the most common cancer in men in Finland wwwcancerregistryfi Although prognosis is very good in majority of men it is noteworthy that still up to 20 of PCa cases are metastatic at the time of initial diagnosis and yearly 900 men die because of prostate cancer Robust primary staging is therefore one of the most important prognostic factors and it is crucial for treatment decision Despite their low sensitivity to detect metastasis bone scintigraphy BS and contrast enhanced whole body computed tomography ce-wbCT are recommended by current guidelines for primary staging in men at risk of metastasis
MIP-1404 is a small-molecule PSMA inhibitor that can be used in SPECT systems 99mTc-MIP- 1404 SPECTCT 99mTc-MIP-1404 SPECTCT is performed by a single IV bolus of 99mTc-MIP-1404 which binds with high affinity to extracellular domain of PSMA molecule As of March 2020 a total of 629 subjects have received 99mTc-MIP-1404 injection averaging 740 111 MBq 20 3 mCi per administration in prospective clinical trials 99mTc MIP-1404 has been well tolerated following a single IV dose at 740 111 MBq in both healthy volunteers and patients with confirmed metastatic prostate adenocarcinoma In prospective and retrospective studies it has shown high potential to detect prostate cancer lesions in primary staging In fact Goffin et al reported a sensitivity of 50 and specificity of 87 detecting local lymph node metastasis in radically operated patients when histopathology was used as a reference This corresponds closely to the sensitivity of PSMA-PET
PROSTAMIP is a randomized prospective single-institutional study to demonstrate superiority of 99mTc-MIP-1404 SPECTCT compared to traditional imaging modalities 99mTc-HMDP planar BS plus ce-wbCT
MIP-1404 is a small-molecule PSMA inhibitor that can be used in SPECT systems 99mTc-MIP- 1404 SPECTCT 99mTc-MIP-1404 SPECTCT is performed by a single IV bolus of 99mTc-MIP-1404 which binds with high affinity to extracellular domain of PSMA molecule As of March 2020 a total of 629 subjects have received 99mTc-MIP-1404 injection averaging 740 111 MBq 20 3 mCi per administration in prospective clinical trials 99mTc MIP-1404 has been well tolerated following a single IV dose at 740 111 MBq in both healthy volunteers and patients with confirmed metastatic prostate adenocarcinoma In prospective and retrospective studies it has shown high potential to detect prostate cancer lesions in primary staging In fact Goffin et al reported a sensitivity of 50 and specificity of 87 detecting local lymph node metastasis in radically operated patients when histopathology was used as a reference This corresponds closely to the sensitivity of PSMA-PET
PROSTAMIP is a randomized prospective single-institutional study to demonstrate superiority of 99mTc-MIP-1404 SPECTCT compared to traditional imaging modalities 99mTc-HMDP planar BS plus ce-wbCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None