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

Phase 1

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Drug: 64Cu-DOTA-ECL1i

• Registration Number: NCT04217057
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Study Start: 2020-02-07
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07
• Results First Submitted: 2024-01-31
• Results First Submitted QC: 2024-01-31
• Results First Posted: 2024-02-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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. Patients who are not surgical candidates should have adequate tissue from tumor biopsy for analysis of CCR2
• 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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64Cu-DOTA-ECL1i-PET/CT	64Cu-DOTA-ECL1i	-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

Primary Outcome Measures

Name	Time	Method
Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale	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
CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining	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.
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	At the time of scan (Day 1)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States