Neoplasms

All Conditions

Wounds and Injuries

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Kishwer Nehal, MD

The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.

Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins

For the primary study objective, the Mohs surgeon will perform a qualitative assessment of the confocal mosaic. This will be a dichotomous assessment of whether the mosaic is of sufficient quality (contrast and resolution) to identify individual features. The specific features for BCC or SCC margins are tumor nests with nuclear atypia and increased nuclear density (relative to the density seen in normal basal cells).

imaging of cancer margins on patients, before Mohs surgery.

Memorial Sloan Kettering Cancer Center

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

use of navigated 3D ultrasound during surgery

Geirmund Unsgaard, MD, PhD

3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.

Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

St. Olavs Hospital

Norwegian University of Science and Technology

Musculoskeletal Diseases

Rare Diseases

Craniopharyngioma

Adamantinoma

Ameloblastoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Neuroepithelioma

Intraoperative imaging and determination of degree of resection / complete tumor removal

Intraoperative imaging using 1.5T MRI

Bernd Hofmann, MD

Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.

1.5T Intraoperative MR Imaging in Craniopharyngiomas

Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")

Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging.

It is examined whether the extent of tumor removal defined prior to surgery was achieved

false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery

Rate of new deficits following surgery (excluding new endocrine deficits)

Hofmann, Bernd, M.D.

Department of Neurosurgery

Symptoms and General Pathology

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Antineoplastic Agents, Immunological

Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.

Indium In 111 Panitumumab

Single Photon Emission Computed Tomography

Computed Tomography

Surgical Procedure

Imaging agent

Intraoperative Imaging

Near Infrared Imaging

Electrocardiography

Biospecimen Collection

Vanderbilt-Ingram Services for Timely Access

Vanderbilt-Ingram Service Services for Timely Access

Eben Rosenthal, MD

This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.

PRIMARY OBJECTIVE:

I. Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC.

SECONDARY OBJECTIVE:

I. Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery.

EXPLORATORY OBJECTIVES:

I. Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative SPECT/CT.

II. When preoperative imaging information (eg, fludeoxyglucose F 18 \[18F-FDG\] positron emission tomography \[PET\]/CT and/or magnetic resonance imaging \[MRI\]) data is available:

IIa. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).

IIb. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative 18F-FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).

OUTLINE:

Patients receive loading dose of panitumumab intravenously (IV) over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and near infrared (NIR) imaging. Patients additionally undergo blood sample collection during screening and electrocardiography (ECG) during screening, on day 0, and on day 15 if indicated.

Patients are followed for up to 15 days after last dose of study medication.

Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer

Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type

Will compare the sensitivity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.

Will compare the specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.

American Cancer Society, Inc.

Vanderbilt-Ingram Cancer Center

Professor of Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pharmaceutical Solutions

Micronutrients

Hematinics

Vitamins

Other Dietary Supplements

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Indole

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

OTL38 for Injection

Near infrared camera imaging system

Sunil Singhal, MD

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation

The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation

The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.

False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Clinipace Worldwide

On Target Laboratories, LLC

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Near infrared camera imaging system: Near infrared camera imaging system

Near-Infrared Imaging Group

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

No Imaging Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Tommy Lee

The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging

Full Analysis Set (FAS)

Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who:

• Were evaluated under both normal light/palpation and NIR fluorescent light imaging

Clinically Significant Events (CSE)

Fully Analysis Set (FAS)

Localization of Primary Nodule

Identification of Cancerous Synchronous Lesions

Positive Resection Margins

Total number of Subjects with Evaluated Tissues

Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects

False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

A custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the injected dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location.

NIR Imaging with FLARE and Mini-FLARE Imaging System

John V. Frangioni, M.D., Ph.D.

The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.

Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.

Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer

To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).

To evaluate the incidence of significant adverse reactions due to both NIR lymphatic mapping and indocyanine green.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins	NCT01872130	Basal Cell Carc... Squamous Cell C...		18 Years -	Memorial Sloan Kettering Cancer Center
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study	NCT00233350	Brain Neoplasms	use of navigate...	18 Years -	Norwegian University of Science and Technology
1.5T Intraoperative MR Imaging in Craniopharyngiomas	NCT01206543	Craniopharyngio...	Intraoperative ...	3 Years - 75 Years	Hofmann, Bernd, M.D.
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study	NCT00233350	Brain Neoplasms	use of navigate...	18 Years -	Norwegian University of Science and Technology
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer	NCT05901545	Head and Neck S... Recurrent Head ...	Panitumumab Indium In 111 P... Single Photon E... Computed Tomogr... Surgical Proced... Imaging agent Intraoperative ... Near Infrared I... Electrocardiogr... Biospecimen Col...	19 Years -	Vanderbilt-Ingram Cancer Center
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting	NCT04241315	Lung Neoplasms Lung Cancer	OTL38 for Injec... Near infrared c...	18 Years -	On Target Laboratories, LLC
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer	NCT01468649	Breast Cancer	NIR Imaging wit...	18 Years -	Beth Israel Deaconess Medical Center
1.5T Intraoperative MR Imaging in Craniopharyngiomas	NCT01206543	Craniopharyngio...	Intraoperative ...	3 Years - 75 Years	Hofmann, Bernd, M.D.

Spots Global Cancer Trial Database for intraoperative imaging