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Monoclonal Antibodies

New Imaging Technique for Kidney Cancer

Phase 2

Recruiting

Led By Brian Shuch

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy < 2 years)

Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy)

Must not have

Known inability to remain still and lie flat during imaging procedure

Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging technique called 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) to see if it is better than the

Who is the study for?

This trial is for individuals who have undergone surgery for clear cell renal cell cancer and are being monitored for possible recurrence of the disease. It's not specified who can't join, but typically, participants need to meet certain health standards.

What is being tested?

The study is testing a new scan called 89Zr-DFO-GmAb PET/CT against the standard contrast-enhanced CT to see if it's better at finding recurrent kidney cancer after surgery. The investigational scan uses a radioactive tracer that targets tumor cells.

What are the potential side effects?

Potential side effects may include reactions to the tracer or contrast agent used in scans, such as allergic reactions or discomfort at injection site. Radiation exposure from PET/CT is also a consideration.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery to remove my kidney cancer and any spread, with no signs of cancer now, all within the last 2 years.

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My kidney cancer was confirmed by surgery.

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I can stay still and lie flat for up to an hour.

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot stay still or lie flat during scans.

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I have signs of cancer remaining or spreading at the time of my planned treatment.

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I cannot have CT scans with iodine-based contrast due to health reasons.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lesion detection rate

Secondary study objectives

Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)

Incidence of adverse events (AEs)

Positive predictive value (PPV)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (89Zr-DFO-GmAb PET/CT)Experimental Treatment7 Interventions

Patients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and SOC diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or MRI of the brain on study as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Bone Scan

2015

Completed Phase 2

~50