NCT04217057

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

Terminated Phase 1 Results posted Last updated 19 November 2024

What this trial tests

Phase 1 trial testing 64Cu-DOTA-ECL1i in Head and Neck Cancer in 11 participants. Terminated before completion.

Timeline

7 February 2020

Primary endpoint
7 February 2023

7 February 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	11
Start date	7 February 2020
Primary completion	7 February 2023
Estimated completion	7 February 2023
Sites	1 location across United States

Drugs / interventions tested

• 64Cu-DOTA-ECL1i — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale Primary · 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

Score of 1

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	0

Score of 2

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	0

Score of 3

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	0

Score of 4

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	11

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 Primary · At the time of scan (Day 1)

Presence of abnormal 64Cu-DOT-ECL1i uptake

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	11

Absence of abnormal 64Cu-DOT-ECL1i uptake

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	0

CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining Primary · 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.

0=absent/faint

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	0

1=weak

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	2

2=moderate

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	5

3=strong

Group	Value	95% CI
64Cu-DOTA-ECL1i-PET/CT	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events will be tracked from start of treatment through study discharge (median follow-up of 17 days, full range 7-40 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

64Cu-DOTA-ECL1i-PET/CT

Serious: 0/11 (0%)

Deaths: 1/11

Other adverse events (3 terms — click to expand)

Reaction	System	64Cu-DOTA-ECL1i-PET/CT
Dry mouth	Gastrointestinal disorders	—
Dysesthesia	Nervous system disorders	—
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT04217057 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
   van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155
2. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
3. Scale down and optimized automated production of [68Ga]68Ga-DOTA-ECL1i PET tracer targeting CCR2 expression.
   Migliari S, Scarlattei M, Baldari G, Ruffini L. · · 2023 · cited 8× · PMID 36729317 · DOI 10.1186/s41181-023-00188-1
4. Chemokine receptor PET imaging: Bridging molecular insights with clinical applications.
   Hunter C, Larimer B. · · 2024 · cited 2× · PMID 38691942 · DOI 10.1016/j.nucmedbio.2024.108912
5. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
   Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321