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64Cu-DOTA-ECL1i for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Farrokh Dehdashti, M.D.

Research Sponsored by Washington University School of Medicine

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 at the time of standard of care surgery (estimated to be within 2 weeks of imaging)

Awards & highlights

Study Summary

This trial will use a new PET radiotracer to study CCR2 in head and neck cancer patients, in order to determine if it can be used as a biomarker for this disease.

Eligible Conditions

Head and Neck Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of standard of care surgery (estimated to be within 2 weeks of imaging)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of standard of care surgery (estimated to be within 2 weeks of imaging)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of standard of care surgery (estimated to be within 2 weeks of imaging) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining

Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale

Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Presence or Absence of Abnormal 64Cu-DOT-ECL1i Uptake in Pathologically Proven Site of Disease

Trial Design

1Treatment groups

Experimental Treatment

Group I: 64Cu-DOTA-ECL1i-PET/CTExperimental Treatment1 Intervention

-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,698 Total Patients Enrolled

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

89 Previous Clinical Trials

19,773 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,568 Total Patients Enrolled

Media Library

64Cu-DOTA-ECL1i Clinical Trial Eligibility Overview. Trial Name: NCT04217057 — Phase 1

Head and Neck Cancers Research Study Groups: 64Cu-DOTA-ECL1i-PET/CT

Head and Neck Cancers Clinical Trial 2023: 64Cu-DOTA-ECL1i Highlights & Side Effects. Trial Name: NCT04217057 — Phase 1

64Cu-DOTA-ECL1i 2023 Treatment Timeline for Medical Study. Trial Name: NCT04217057 — Phase 1

Frequently Asked Questions

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

Is enrollment still active for this experiment?

"Verified; according to the clinicaltrials.gov portal, this medical investigation is currently recruiting participants. It was first announced on February 7th 2020 and last revised August 30th 2022 – with a target of 20 patients at one site."

Answered by AI

Has the FDA accepted 64Cu-DOTA-ECL1i for use in medical treatments?

"Due to the preliminary nature of this trial, 64Cu-DOTA-ECL1i was given a rating of 1 in terms of safety. This is because there is limited data supporting both efficacy and risk mitigation at this stage."

Answered by AI

How many individuals are being included in this trial?

"Affirmative, the records hosted on clinicaltrials.gov demonstrate that this medical experiment is actively recruiting participants. The trial was initiated February 7th 2020 and most recently edited on August 30th 2022. Currently, 20 subjects are being accepted from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer

2020. "Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04217057.