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Magnetic Resonance Imaging for Prostate Adenocarcinoma

Phase 2 & 3
Waitlist Available
Research Sponsored by Andrei Iagaru
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial is testing how well a new scan (68Ga-RM2 PET/MRI) works in detecting prostate cancer in patients who have had surgery or radiation and have an elevated prostate-specific antigen level but a negative CT scan.

Eligible Conditions
  • Prostate Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Tumor Lesions Detected by 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI
Sensitivity of MRI Alone vs PET/MRI
Specificity of MR Alone vs PET/MRI

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293
19%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (68Ga-RM2 PET/MRI)Experimental Treatment3 Interventions
Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-RM2
2015
Completed Phase 3
~190
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

Andrei IagaruLead Sponsor
15 Previous Clinical Trials
474 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of RoentgenologyJournal
Reduced Acquisition Time Per Bed Position for PET/MRI Using <sup>68</sup>ga-rm2 or <sup>68</sup>ga-psma-11 in Patients with Prostate Cancer: A Retrospective Analysis
Duan, Heying, Lucia Baratto, Negin Hatami, Tie Liang, Craig S. Levin, Mohammad Mehdi Khalighi, and Andrei Iagaru. 2022. “Reduced Acquisition Time Per Bed Position for PET/MRI Using 68ga-rm2 or 68ga-psma-11 in Patients with Prostate Cancer: A Retrospective Analysis”. American Journal of Roentgenology. American Roentgen Ray Society. doi:10.2214/ajr.21.25961.
Journal of Nuclear MedicineJournal
PSMA- and Grpr-targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer
Baratto, Lucia, Hong Song, Heying Duan, Negin Hatami, Hilary P. Bagshaw, Mark Buyyounouski, Steven Hancock, et al.. 2021. “PSMA- and Grpr-targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.120.259630.
American Journal of RoentgenologyJournal
Reduced Acquisition Time Per Bed Position for PET/MRI Using <sup>68</sup>ga-rm2 or <sup>68</sup>ga-psma-11 in Patients with Prostate Cancer: A Retrospective Analysis
Duan, Heying, Lucia Baratto, Negin Hatami, Tie Liang, Craig S. Levin, Mohammad Mehdi Khalighi, and Andrei Iagaru. 2022. “Reduced Acquisition Time Per Bed Position for PET/MRI Using 68ga-rm2 or 68ga-psma-11 in Patients with Prostate Cancer: A Retrospective Analysis”. American Journal of Roentgenology. American Roentgen Ray Society. doi:10.2214/ajr.21.25961.
clinicaltrials.govStudy
68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer
Andrei Iagaru 2015. "68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02624518.
~13 spots leftby Apr 2025
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