Head and Neck Cancer
Conditions
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.
Interventions
DRUG64Cu-DOTA-ECL1i
Will be produced by the Cyclotron Facility at Washington University School of Medicine
Sponsors
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) | — |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | 64Cu-DOTA-ECL1i-PET/CT |
|---|---|
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 00 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: At the time of standard of care surgery (estimated to be within 2 weeks of imaging)
Population: One participant did not have tissue avaiable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 64Cu-DOTA-ECL1i-PET/CT | CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining | 3=strong | 3 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining | 0=absent/faint | 0 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining | 1=weak | 2 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining | 2=moderate | 5 Participants |
Primary
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
Time frame: At the time of scan (Day 1)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 64Cu-DOTA-ECL1i-PET/CT | Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale | Score of 1 | 0 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale | Score of 2 | 0 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale | Score of 3 | 0 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale | Score of 4 | 11 Participants |
Primary
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
Time frame: At the time of scan (Day 1)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 64Cu-DOTA-ECL1i-PET/CT | 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 | Presence of abnormal 64Cu-DOT-ECL1i uptake | 11 Participants |
| 64Cu-DOTA-ECL1i-PET/CT | 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 | Absence of abnormal 64Cu-DOT-ECL1i uptake | 0 Participants |