Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Anti-Infective Agents

Fluorodeoxyglucose F18

Deoxyglucose

After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FDG intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained.And then underwent whole body static PET scan.

Dynamic PET

Hongjun Jin, Ph.D

Hong Shan, Ph.D

Currently, static scans are commonly used for Positron Emission Tomography/Computed Tomography (PET/CT) examination in the literature. Accordingly, functional images of 2-\[18F\]fluoro-2-deoxy-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) with dynamic scans can be more sensitive to detect metastatic lymph node, since the introduction of temporal dynamic variables would provide more imaging quantification than conventional static scans. The purpose of this study is to provide the dynamic 18F-FDG PET/CT imaging for esophageal squamous cell carcinoma (ESCC) patient to quantify the difference between malignant lymph nodes (MLN) and benign lymph nodes (BLN).

Esophageal cancer is one of the most aggressive malignancies in the world, which accounted for an estimated 572,034 new cases and 508,585 deaths in 2018 worldwide. The incidence and mortality of esophageal cancer is ranked first in China and esophageal squamous cell carcinoma (ESCC) is the main histological subtype of esophageal cancers in China. Correct preoperative evaluation of whether the tumor has reached any lymph nodes is important for management. Various methods have been used to detect primary and lymph node metastases in esophageal cancer patients, including computed tomography (CT), endoscopic examinations, and endoscopic ultrasonography (EUS). However, even such advanced imaging modalities do not always reliably identify lymph node metastasis prior to surgical resection and pathological examination.

The appearance of lymph nodes with morphological imaging procedures is classified by their shape, size, density and, if applied, contrast enhancement. BLN usually tend to have a fatty hilum, an oval shape and frequently do not measure more than 1 cm in the short axis diameter. However, the use of size as the most important criterion for differentiation of benign and malignant lymph nodes has limitations: small metastases without an increase in lymph node size are frequently missed. Positron emission tomography (PET)/computed tomography (CT) is increasingly used as single "one stop shop" method, which the combination of morphological and functional imaging represents the optimal approach for lymph node staging and general staging. A radioactive tracer，2-\[18F\]fluoro-2-deoxy-glucose (18F-FDG) currently used is based on the increased glucose metabolism, which may be reported with semiquantitative standard uptake value (SUV). Routinely, 18F-FDG is intravenous injected and PET/CT scan is performed after 60 min. The static imaging in differentiation of inflammatory from MLN may be problematic. Because inflammatory lymph nodes goes along with an increase in glucose metabolism, and thus may manifest increased 18F-FDG uptake. It was reported that PET-CT sensitivity and specificity for the detection of loco-regional metastases were moderate, but sensitivity and specificity were reasonable for distant metastases. Many researchers found there is a correlation between the 18F-FDG uptake and time. In malignancy, the uptake of FDG uptake continues to increase for several hours after FDG injection whereas such prolonged period of FDG uptake is rare in inflammatory/infectious or normal tissues. Shum et al ever assessed clinical usefulness of dual-time FDG PET/CT in esophageal squamous cell carcinoma, which turned out the sensitivity of FDG PET-CT in detecting the primary ESCC with combination of early maximum standard uptake value (SUVmax) ≥2.5 or retention index (RI) ≥10% was 96.2%. However, for loco-regional lymph node detection, there was no significant difference using dual-time 18F-FDG PET/CT assessment. Dynamic 18F-FDG PET/CT allows quantitative assessment of lesion in vivo by using a Patlak model to obtain the influx constant (Ki), and the glucose metabolic rate (MRglu). The purpose of the study is to determine whether the dynamic 18F-FDG PET/CT imaging (0-60 min) add additional value in differentiation MLN from BLN.

Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 18F-FDG PET/CT in Patients With ESCC

Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 2-[18F]Fluoro-2-deoxy-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography in Patients With Esophageal Squamous Cell Carcinoma

The sensitivity for each parameter in differentiating malignant and benign lymph nodes were evaluated

The specificity for each parameter in differentiating malignant and benign lymph nodes were evaluated

The accuracy for each parameter in differentiating malignant and benign lymph nodes were evaluated

Ki of each MLN and BLN were calculated and compared

MRglu of each MLN and BLN were calculated and compared

SUVmax of each MLN and BLN were calculated and compared

SUVmax 60/30 of each MLN and BLN were calculated and compared

Ki of each primary tumor between N0 and non-N0 stagewere calculated and compared

MRglu of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.

SUVmax of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.

SUVmax 60/30 of each primary tumor between N0 and non-N0 stagewere calculated and compared

Fifth Affiliated Hospital, Sun Yat-Sen University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Mitogens

Maximum 15 evaluable subjects with HER2-positive status in primary tumour before chemo/targeted therapy have to be enrolled in the study.

Subjects withdrawn from the study for any reason will be replaced.

Maximum 15 evaluable subjects with HER2-negative status in primary tumour before chemo/targeted therapy have to be enrolled in the study.

Subjects withdrawn from the study for any reason will be replaced.

Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes

ADAPT6-SPECT

Vladimir I Chernov, MD, PhD

An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.

Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes

99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled ADAPT6 Molecule-based 99mTc-ADAPT6.

SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV

SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV

The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with LN lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

Comparison of the 99mTc-ADAPT6 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 18F-FDG PET/CT in Patients With ESCC	NCT04514822	Esophageal Squa... Positron Emissi...	Dynamic PET	18 Years - 85 Years	Fifth Affiliated Hospital, Sun Yat-Sen University
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes	NCT05412446	Breast Cancer Female	ADAPT6-SPECT	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes	NCT05412446	Breast Cancer Female	ADAPT6-SPECT	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes	NCT05412446	Breast Cancer Female	ADAPT6-SPECT	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes	NCT05412446	Breast Cancer Female	ADAPT6-SPECT	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences

Spots Global Cancer Trial Database for metastatic lymph nodes