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MRI Coil

mpMRI with Flexible AIR Coil for Prostate Cancer

N/A

Recruiting

Led By Tharakeswara Bathala

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade ≥2) adenocarcinoma of the prostate

Male, Age ≥ 18

Must not have

Claustrophobia and/or receiving anesthesia

A history of other active malignancy within the last 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial shows that mpMRI of the prostate helps accurately diagnose prostate cancer while reducing unnecessary biopsies. It's useful for active surveillance & surgical planning.

Who is the study for?

Men over 18 with intermediate to high-risk prostate cancer that hasn't been treated yet. They must be eligible for a specific type of MRI scan and considering surgery within the next 6 months. Excluded are those with certain types of prostate cancer, prior treatments, or conditions like severe hemorrhoids, recent surgeries, other active cancers in the last two years, pacemakers, or claustrophobia.

What is being tested?

The study is testing how well two different MRI techniques using flexible AIR coils and endorectal coils can identify clinically significant prostate cancer. It aims to see if these methods can help avoid unnecessary biopsies by better detecting aggressive cancers needing treatment versus less serious ones that might only need monitoring.

What are the potential side effects?

While not explicitly mentioned for this diagnostic trial, potential side effects may include discomfort from lying still during the MRI scan or reactions related to contrast agents used (if any), such as mild pain at injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is aggressive and hasn't been treated yet.

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have claustrophobia or need anesthesia for procedures.

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I have not had any other cancer in the last 2 years.

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I have received treatment for prostate cancer before.

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My prostate cancer has specific aggressive features.

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I cannot have an endorectal coil due to rectal issues.

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I have metal implants in my pelvis or spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

will have an mpMRI scan with an endorectal coil

Group II: Group 1Experimental Treatment1 Intervention

will have an mpMRI scan with a flexible AIR coil.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,443 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,399 Patients Enrolled for Prostate Cancer

Tharakeswara BathalaPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

163 Total Patients Enrolled

1 Trials studying Prostate Cancer

33 Patients Enrolled for Prostate Cancer

Tharakeswara Bathala, MBBS,MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

2 Total Patients Enrolled

Media Library

Flexible AIR Coil (MRI Coil) Clinical Trial Eligibility Overview. Trial Name: NCT05043012 — N/A

Prostate Cancer Research Study Groups: Group 1, Group 2

Prostate Cancer Clinical Trial 2023: Flexible AIR Coil Highlights & Side Effects. Trial Name: NCT05043012 — N/A

Flexible AIR Coil (MRI Coil) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05043012 — N/A

~134 spots leftby Feb 2027

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