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

Primary Purpose

Head and Neck Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

64Cu-DOTA-ECL1i

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

64Cu-DOTA-ECL1i-PET/CT

Arm Description

-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

Outcomes

Primary Outcome Measures

Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by assessment of overall image quality: 4 point scale

-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

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

CCR2 detection rate of 64Cu-DOTA-ECL1i-PET/CT as measured by IHC staining

-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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04217057

First Posted

December 30, 2019

Last Updated

September 2, 2023

Sponsor

Washington University School of Medicine

Collaborators

National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

1. Study Identification

Unique Protocol Identification Number

NCT04217057

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2020 (Actual)

Primary Completion Date

January 15, 2025 (Anticipated)

Study Completion Date

January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

64Cu-DOTA-ECL1i-PET/CT

Arm Type

Experimental

Arm Description

-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

Intervention Type

Drug

Intervention Name(s)

64Cu-DOTA-ECL1i

Intervention Description

Will be produced by the Cyclotron Facility at Washington University School of Medicine

Primary Outcome Measure Information:

Title

Diagnostic quality of 64Cu-DOTA-ECL1i-PET/CT images as measured by assessment of overall image quality: 4 point scale

Description

Time Frame

At the time of scan (Day 1)

Title

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)

Title

CCR2 detection rate of 64Cu-DOTA-ECL1i-PET/CT as measured by IHC staining

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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. 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Farrokh Dehdashti, M.D.

Phone

314-362-1474

dehdashtif@mir.wustl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Frye, CNMT, CCRC

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farrokh Dehdashti, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farrokh Dehdashti, M.D.

Phone

314-362-1474

dehdashtif@mir.wustl.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Frye, CNMT, CCRC

Phone

314-747-1604

fryej@mir.wustl.edu

First Name & Middle Initial & Last Name & Degree

Farrokh Dehdashti, M.D.

First Name & Middle Initial & Last Name & Degree

Ryan Jackson, M.D.

First Name & Middle Initial & Last Name & Degree

Yongjian Liu, Ph.D.

First Name & Middle Initial & Last Name & Degree

Ningwing Wu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Kooresh I Shoghi, Ph.D.

First Name & Middle Initial & Last Name & Degree

Rebecca Chernock, M.D.

First Name & Middle Initial & Last Name & Degree

Chieh-Yu Lin, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Richard Laforest, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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