CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma
2026년 6월 15일 업데이트: Washington University School of Medicine
This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET/CT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).
연구 개요
상태
아직 모집하지 않음
개입 / 치료
연구 유형
중재적
등록 (추정된)
90
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Farrokh Dehdashti, MD
- 전화번호: 314-362-1474
- 이메일: dehdashtif@wustl.edu
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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연락하다:
- Farrokh Dehdashti, MD
- 전화번호: 314-362-1474
- 이메일: dehdashtif@wustl.edu
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부수사관:
- Ningying Wu, MD, PhD
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부수사관:
- Douglas Adkins, MD
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부수사관:
- Yongjian Liu, PhD
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부수사관:
- Ryan Jackson, MD
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부수사관:
- Sidharth Puram, MD, PhD
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부수사관:
- Chieh-Yu Lin, MD, PhD
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부수사관:
- Richard Laforest, PhD
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부수사관:
- Ying Hwey Nai, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult patient 18 years of age or older
- Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent/metastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll
- Lesion size of at least 1.0 cm in longest dimension by conventional imaging.
- Able to give informed consent
- Not currently pregnant or nursing: Female subjects 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 24 hour period immediately prior to administration of Cu-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 60 min (total time) of PET/CT imaging
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1: Newly Diagnosed HNSCC who are scheduled to undergo surgical resection
Cohort 1 will undergo 64Cu-DOTA-ECL1i positron emission tomography-computed tomography (PET/CT) once prior to scheduled standard of care (SOC) surgery and prior to any neoadjuvant therapy. Participants will be followed up via a phone call or in-person visit 24 hours - 14 days after 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments. |
64Cu-DOTA-ECL1i a novel PET imaging tracer that will be provided intravenously (IV) while participants will be positioned supine on the on the scanning table.
The injection will be followed with saline flush.
다른 이름들:
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실험적: Cohort 2: Recurrent/metastatic HNSCC who are candidates for first-line anti-PD1 therapy
Cohort 2 subjects will undergo 64Cu-DOTA-ECL1i PET imaging twice, once at baseline prior to the start of anti-PD1 therapy and after 3 cycles of therapy (within 14 days of cycle 4 day 1). Participants will be followed up via a phone call or in-person visit 24 hours - 14 days after baseline 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments. |
64Cu-DOTA-ECL1i a novel PET imaging tracer that will be provided intravenously (IV) while participants will be positioned supine on the on the scanning table.
The injection will be followed with saline flush.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cohort 1 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
기간: At baseline prior to scheduled surgery (estimated time frame: 1 day)
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64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax).
SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio.
SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan.
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At baseline prior to scheduled surgery (estimated time frame: 1 day)
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Cohort 1 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
기간: At time of surgery (total estimated time up to 14 days)
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Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor.
Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake.
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At time of surgery (total estimated time up to 14 days)
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Cohort 2 only: Semiquantitative 64Cu-DOTA-ECL1i PET/CT uptake
기간: At baseline (estimated time frame: 1 day)
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64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax).
SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body) and/or tumor-to-normal-tissue-ratio.
SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan
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At baseline (estimated time frame: 1 day)
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Cohort 2 only: Quantitative 64Cu-DOTA-ECL1i PET/CT uptake
기간: At time of surgery (total estimated time up to 14 days)
|
Quantitative 64Cu-DOTA-ECL1i PET uptake will be assessed via a Logan/Patlak analysis to characterize the pharmacokinetics of the tumor.
Logan/Patlak is a graphical analysis which uses linear regression to analyze the pharmacokinetics of tracers involving reversible uptake.
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At time of surgery (total estimated time up to 14 days)
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Cohort 1 only: CCR2 expression in tumor tissue
기간: At time of surgery (total estimated time up to 14 days)
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CCR2 expression will be analyzed in tumor tissue specimens obtained from surgical specimens collected at resection and from archival biopsy specimens obtained prior to neoadjuvant therapy.
CCR2 expression will be examined using flow cytometry and RT-PCR.
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At time of surgery (total estimated time up to 14 days)
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Cohort 2 only: Change in 64Cu-DOTA-ECL1i PET uptake from baseline to post-cycle 3 imaging
기간: At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
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64Cu-DOTA-ECL1i PET uptake will be assessed using standardized update value maximum (SUVmax).
SUV is a decay-corrected measurement of activity per volume of tissue (µCi/mL) divided by the average activity per unit mass in the entire body and/or tumor-to-normal-tissue-ratio.
SUVmax is the highest measured uptake of a tracer of a lesion on a PET scan.
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At baseline and post cycle 3 imaging (estimated time frame up to 9 weeks)
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Cohort 2 only: Objective response
기간: Enrollment until date of completion of follow-up, date of disease progression, or time of death, whichever occurs first (estimated total time to be 12 months)
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Objective response will be assessed according to RECIST 1.1.
Objective response is defined as categorized as responder versus non-responder based on best overall response.
Responder is defined as best overall response as complete or partial response.
Non-responder is defined as best overall response as stable disease or progressive disease.
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Enrollment until date of completion of follow-up, date of disease progression, or time of death, whichever occurs first (estimated total time to be 12 months)
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Cohort 2 only: Progression-free survival (PFS)
기간: Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
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PFS is defined from anti-PD1 treatment start date to date of progression or date of death due to any cause.
PFS will be analyzed by the Kaplan-Meier method.
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Start of anti-PD1 treatment to date of disease progression or death from any cause (total estimated time to be 12 months)
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Cohort 2 only: Overall survival (OS)
기간: Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)
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OS is defined from start of treatment to death due to any cause or last date of follow up.
Alive patients are censored at the last follow-up otherwise.
OS will be analyzed by the Kaplan-Meier method.
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Start of anti-PD1 treatment to date of death from any cause (total estimated time to be 12 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Farrokh Dehdashti, MD, Washington University School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 31일
기본 완료 (추정된)
2032년 3월 31일
연구 완료 (추정된)
2032년 3월 31일
연구 등록 날짜
최초 제출
2026년 6월 15일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202605001
- R01CA311209 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via the digital repository Digital Commons@Becker.
IPD 공유 기간
Data will be available as soon as possible, but no later than the time of publication or the end of the funding period, whichever comes first.
The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .