Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Work package I: In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected. Work package II: In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed: - sensitivity, specificity, positive and negative predictive values of FLI; - colocalization with immunohistochemistry; - change in surgical management; incremental operation time; - FLI of excised cervical lymph nodes. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT06236464 -
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
|
||
Terminated |
NCT04659369 -
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT02572778 -
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
|
||
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
Terminated |
NCT01488318 -
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT00999700 -
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
|
Phase 3 | |
Completed |
NCT02565758 -
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT02543476 -
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
|
N/A | |
Recruiting |
NCT03938012 -
Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma
|
||
Terminated |
NCT02124850 -
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
|
Phase 1 | |
Active, not recruiting |
NCT03313804 -
Priming Immunotherapy in Advanced Disease With Radiation
|
Phase 2 | |
Recruiting |
NCT05208762 -
A Study of SGN-PDL1V in Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT04453046 -
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
|
N/A | |
Completed |
NCT01758731 -
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
|
Phase 1 | |
Completed |
NCT02473731 -
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients
|
Phase 1 | |
Completed |
NCT02022098 -
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
|
N/A | |
Completed |
NCT01458392 -
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
Completed |
NCT02882308 -
Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.
|
Phase 2 |