Trial Outcomes & Findings for Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer (NCT NCT04217057)
NCT ID: NCT04217057
Last Updated: 2024-11-19
Results Overview
-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
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
At the time of scan (Day 1)
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
64Cu-DOTA-ECL1i-PET/CT
n=11 Participants
-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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|---|---|
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Age, Continuous
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62 years
n=99 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
00 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
64Cu-DOTA-ECL1i-PET/CT
n=11 Participants
-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
|
|---|---|
|
Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale
Score of 1
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0 Participants
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At the time of scan (Day 1)Outcome measures
| Measure |
64Cu-DOTA-ECL1i-PET/CT
n=11 Participants
-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
|
|---|---|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: At the time of standard of care surgery (estimated to be within 2 weeks of imaging)Population: One participant did not have tissue avaiable.
-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.
Outcome measures
| Measure |
64Cu-DOTA-ECL1i-PET/CT
n=10 Participants
-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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CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining
0=absent/faint
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0 Participants
|
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CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining
1=weak
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2 Participants
|
|
CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining
2=moderate
|
5 Participants
|
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CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining
3=strong
|
3 Participants
|
Adverse Events
64Cu-DOTA-ECL1i-PET/CT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
64Cu-DOTA-ECL1i-PET/CT
n=11 participants at risk
-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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Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Adverse events will be tracked from start of treatment through study discharge (median follow-up of 17 days, full range 7-40 days)
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|
Nervous system disorders
Dysesthesia
|
9.1%
1/11 • Adverse events will be tracked from start of treatment through study discharge (median follow-up of 17 days, full range 7-40 days)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
9.1%
1/11 • Adverse events will be tracked from start of treatment through study discharge (median follow-up of 17 days, full range 7-40 days)
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Additional Information
Dr. Farrokh Dehdashti
Washington University School of Medicine
Phone: 314-362-1474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place