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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217057
Recruitment Status : Suspended (COVID-19)
First Posted : January 3, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: 64Cu-DOTA-ECL1i Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 64Cu-DOTA-ECL1i-PET/CT
-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
Drug: 64Cu-DOTA-ECL1i
Will be produced by the Cyclotron Facility at Washington University School of Medicine




Primary Outcome Measures :
  1. Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by assessment of overall image quality: 4 point scale [ Time Frame: At the time of scan (Day 1) ]
    -Overall image quality will be graded on a 4 point scale with 1 being the worse and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies

  2. Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by presence of absence of abnormal 64Cu-DOT-ECL1i uptake in pathologically proven site of disease [ Time Frame: At the time of scan (Day 1) ]
  3. CCR2 detection rate of 64Cu-DOTA-ECL1i-PET/CT as measured by IHC staining [ Time Frame: At the time of standard of care surgery (estimated to be within 2 weeks of imaging) ]
    -Intensity of CCR2 signal in IHC will be assessed by the study pathologist and categorized into 4 categories (0=absent/faint, 1=weak, 2=moderate, 3=strong). Any cells that stained positively with CCR2 will be assessed and the final score will be based on an overall assessment of CCR2 IHC on all of these cells.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient 18 years of age or older
  • Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated with standard of care surgery
  • Lesion size of at least 1.5 cm (treatment naïve)
  • Able to give informed consent
  • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 14 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is negative

Exclusion Criteria:

  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years
  • Unable to tolerate approximately 90 minutes (total time) of PET/CT imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217057


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Farrokh Dehdashti, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04217057    
Other Study ID Numbers: 201912003
1P41EB025815-01 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms