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PET/MRI for Prostate Cancer

Phase 1

Recruiting

Led By Karim Touijer, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new cancer-detecting tracer to see if it's more accurate than current imaging methods.

Who is the study for?

Men over 18 with prostate cancer who are fit for surgery and scheduled for a specific type of operation to remove the prostate or salvage lymph node dissection. They must have certain tumor characteristics like size, shape, or PSA levels. Excluded are those with prior pelvic radiotherapy (except for some cases), weight over 400 lbs, severe claustrophobia, metal implants incompatible with MRI, recent heart issues, kidney problems or uncontrolled infections.Check my eligibility

What is being tested?

The trial is testing a new tracer called 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots during surgery to see if it's better at finding cancer cells than current imaging methods. Participants will undergo PET/MRI scans after receiving this experimental tracer to track its distribution in the body.See study design

What are the potential side effects?

Since this is the first use of the tracer in humans undergoing prostate surgery, potential side effects aren't fully known but may include reactions related to injection such as pain or swelling at the site, allergic responses and any risks associated with PET/MRI scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a laparoscopic prostate surgery.

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I have had a salvage pelvic lymph node dissection.

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I have had surgery to remove my prostate and pelvic lymph nodes.

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I have a suspicious lymph node detected by imaging tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Side effects

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prostate cancer patientsExperimental Treatment4 Interventions

Patients will receive an intravenous (IV) injection of approximately 5 mCi (+/- 10%) of PSMAtargeting C' dot tracer up to 48 hours before surgery. Patients will then undergo serial preoperative PET/MR imaging to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/MRI

2013

Completed Phase 2

~550

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,895 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,085 Patients Enrolled for Prostate Cancer

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,916 Total Patients Enrolled

132 Trials studying Prostate Cancer

52,064 Patients Enrolled for Prostate Cancer

Elucida OncologyIndustry Sponsor

2 Previous Clinical Trials

166 Total Patients Enrolled

Media Library

PET/MRI Clinical Trial Eligibility Overview. Trial Name: NCT04167969 — Phase 1

Prostate Cancer Research Study Groups: Prostate cancer patients

Prostate Cancer Clinical Trial 2023: PET/MRI Highlights & Side Effects. Trial Name: NCT04167969 — Phase 1

PET/MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167969 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can PET/MRI be trusted to not cause adverse effects in patients?

"While preliminary, there is sufficient evidence to suggest that PET/MRI poses minimal risk. Therefore, it receives a score of 1 on our safety scale."

Answered by AI

What is the total participant count of this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial is actively recruiting, having initially been posted on February 17th 2021 and most recently updated on March 7th 2022. 10 test subjects are being sought at a single site of investigation."

Answered by AI

Are there vacancies for participants in this trial?

"Affirmative. According to data hosted on clinicaltrials.gov, this experiment is now recruiting participants. It was first published in February 17th 2021 and its details have been modified as recently as March 7th 2022. The study requires 10 patients from a singular location for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

2021. "The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04167969.

All > Prostate Cancer New York