68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
NCT ID: NCT02559115
Last Updated: 2021-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2015-09-21
2020-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET/CT imaging with 68Ga-RM2
The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass \<= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC.
68Ga-RM2 (RM2)
PET/CT Scan
Interventions
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68Ga-RM2 (RM2)
PET/CT Scan
Eligibility Criteria
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Inclusion Criteria
* Biopsy proven adenocarcinoma of the prostate
* Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
* Planned radical prostatectomy at MSKCC
* Multiparametric MRI of the pelvis (performed or planned) as routine care
Exclusion Criteria
* Platelets \<75K/mcL
* ANC \<1.0 K/mcL
* Hepatic laboratory values
* Bilirubin \>2.0 x ULN (institutional upper limits of normal)
* AST/ALT \>2.5 x ULN
* Renal laboratory values
o Creatinine \> 2.0 x ULN
* Claustrophobia interfering with MRI and PET/CT imaging
* Prior pelvic radiation
* Prior androgen deprivation therapy
* Patients deemed not surgical candidates due to prohibitive co-morbidities
18 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Herbert Vargas Alvarez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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14-146
Identifier Type: -
Identifier Source: org_study_id
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