Neoplasms

All Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Carcinoma

Neoplasm Metastasis

Thyroid Neoplasms

Thyroid Diseases

Lymphatic Metastasis

Neoplastic Processes

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

All patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg

Bevacizumab-IRDye800CW

Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND.

Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis.

Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients.

Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.

Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW

Thyroid Cancer and Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW With Molecular Fluorescence Guided Surgery. Thyroid cAncer Surgery With Intraoperative Molecular fluoRescent Imaging to rEduce overtreatmenT and Morbidity

Dutch Cancer Society

University Medical Center Groningen

Digestive System Diseases

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Malignancy determination of new onset hepatic lesion

Tracks and localizes intrahepatic lesions

Optical Molecular Imaging

Fluorescent dye used for visualization of cells and tissue

Indocyanine Green

Bradford J Wood, M.D.

Background:

Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. This study will look at combining two devices to provide better liver samples.

Objective:

To see if combining fusion imaging and optical imaging can better sample areas of concern in the liver and determine the presence of disease.

Eligibility:

People ages 18 and older who need a liver biopsy as part of diagnosis or treatment.

Design:

Participants will be screened with:

Review of imaging

Medical history

Physical exam

Blood test results

Participants will have a dye injected into a vein 24 hours before their biopsy. They will be monitored for 30 minutes for any side effects.

For the biopsy, participants skin will be numbed. They may have stickers placed on their belly to help guide the needle. They will have a CT scan to plan the needle s pathway. For the scan, they will lie in a machine that takes pictures of the body. A small camera will be placed near the needle to take pictures of the liver. A medical GPS tracking system will be used. This will guide the needle into the area of the participant s liver where the biopsy will be taken.

After the biopsy, participants will recover in the hospital for 4 6 hours.

After the procedure, researchers will take the participants biopsy tissue and look at it to try to compare new ways to picture the sample.

* Pilot study to evaluate the combination of optical molecular imaging (OMI) and EM tracking in localizing intrahepatic lesions and assess the concordance between fluorescence ICG and histopathology for the diagnosis of liver cancer.
* Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide. Percutaneous sampling of focal hepatic lesions is a cornerstone in management of patients with hepatic pathology. In a retrospective study of patients with small hepatic lesions, up to 45% of the lesions biopsied were insufficiently visualized and resulted to a false negative rate (defined as patients with benign biopsies who were subsequently found to have malignant lesions at the attempted site of biopsy). Thirty seven percent of those were for HCC.
* EM navigation and fusion of real-time images with pre-acquired scans has been used in hepatic biopsies at the NIH for more than 15 years. NIH / NCI clinical trials have performed fusion biopsies with EM tracking in \> 2000 patients, \> 40,000 biopsies over the past 12 years.
* Indocyanine green (ICG) is an FDA approved optical molecular imaging fluorescent dye used for visualization of cells and tissues. ICG has been used for decades in ophthalmology for imaging retinal blood vessels. ICG was FDA cleared in 1959 and has been widely used to assess liver function perioperatively. ICG is administered as an injection. Adverse effects are rare and most often minor.

Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

A Feasibility Study to Evaluate the Combination of Electromagnetic Tracking and Optical Imaging With Indocyanine Green (ICG) for Hepatic Biopsies

Measurements will be obtained during hepatic biopsy procedure

Assess concordance of ICG fluorescence at invivo site of biopsy with presence or absence of malignancy as defined by pathology

Assess concordance of ICG fluorescence at exvivo site of biopsy with presence or absence of malignancy as defined by pathology

National Institutes of Health Clinical Center (CC)

All patients will receive a dose of ICG 0.5mg/kg, with a maximum dose of 40mg, one day prior to the scheduled procedure. The patients will then undergo a routine image-guided biopsy on the day of the procedure; immediately prior to obtaining the biopsy sample, fluorescence intensity within the target lesion will be measured by a handheld optical molecular imaging device, which will be passed through the biopsy needle. Once the core sample is obtained using a standard biopsy needle, the specimen will be imaged using an epifluorescence, point-of-care imaging system and will then be submitted for standard pathologic analysis.

Optical molecular imaging

Umar Mahmood, MD, PhD

This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies.

In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a part of their medical care. By participating in this trial, the only additional requirement will be for the participant to come to the hospital on the day prior to their scheduled biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the amount of ICG that is in the participant's liver tumor by using two experimental devices designed by the study investigators that shine light on tissue. One device consists of an imaging system attached to a small borescope that will go inside the participant's body during the biopsy. The second device shines light on the biopsy sample outside of the participant's body after the biopsy has been taken. The participant may undergo imaging with one or both of these devices.

Before the research starts (screening): After signing this consent form, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.

* A medical history, which includes questions about the participant's health, current medications, and any allergies.
* Performance status, which evaluates how the participant is able to carry on with their usual activities.
* An assessment of your liver by X-ray, ultrasound, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
* Anesthesia score, which evaluates how the participant tolerates the sedation given with biopsies.
* Blood tests.

If these tests show that the participant is eligible to participate in the research study, the participant will receive the study agent. If the participant does not meet the eligibility criteria, then the participant will not be able to participate in this research study.

After the screening procedures confirms that the participant is eligible to participate in the research study: The participant will be scheduled for their regular CT- or ultrasound-guided liver biopsy. On the day prior to the procedure, the participant will come to our Interventional Radiology waiting area at Massachusetts General Hospital. After the participant arrives, the participant will be interviewed by a research doctor and receive a dose of ICG intravenously. The participant will be monitored for 30 minutes after the injection, and after this time, the participant will be free to leave. On the day of the procedure, the participant will come back to the Interventional Radiology waiting area. After the participant arrives, the participant will receive an intravenous line. The participant may also have some blood drawn (no more that 4 tablespoons) for any tests needed in addition to blood work done before the participant was enrolled in the study. The participant will then meet again with the research doctor, who will go over the procedure with the participant and as usual obtain their consent to have the standard liver biopsy. The nurse will begin administering the sedatives until the participant is comfortable to proceed with the procedure. The research doctor and his assistant will advance a hollow biopsy needle through the skin and into the lesion in the liver. A miniature endoscope, small enough to fit through the hollow center of the biopsy needle, will then be passed through the needle so that the tip of the endoscope is within the lesion. The fluorescence within the lesion will be measured with the endoscope by a special camera attached to the back of the endoscope. The endoscope will then be removed, and the lesion will be biopsied with a standard biopsy needle. If the participant is undergoing a biopsy of the liver to obtain a sample of their liver tissue and not a specific area in the liver, the endoscopic imaging described above will not be performed. The biopsy will be performed in the usual way. Once the biopsy is performed, the sample of tissue from the biopsy will be imaged by a special camera and computer that will be within the procedure room. The added steps for this trial should only add approximately 5 minutes to the procedure time.

After the procedure: After the procedure is complete, the investigator will bring the participant to the recovery room so that the participant can sleep off the sedative medications. Throughout this time, the participant will be observed by a nurse, and vital signs will be monitored. The participant will be given the usual post-procedure instructions. The investigator would like to keep track of your medical condition after the procedure to make sure no side effects have occurred. The investigator would like to do this by calling the participant on the telephone the day after the procedure and 1 week after the procedure.

A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green

We hypothesize that HCC lesions will have significantly higher fluorescence intensity following ICG administration that normal/cirrhotic liver parenchyma. This will allow the proceduralist to recognize during the procedure whether the target lesion has been sampled accurately. We also hypothesize that OMI will characterize malignant lesions with \>90% accuracy prior to core biopsy, with standard of care histology and follow up imaging as the gold standard. Benign and malignant lesions will have significantly different ICG uptake to allow for their differentiation based on their ICG fluorescence signal intensity measured percutaneously.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW	NCT06095362	Thyroid Carcino... Surgery	Bevacizumab-IRD...	18 Years -	University Medical Center Groningen
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW	NCT06095362	Thyroid Carcino... Surgery	Bevacizumab-IRD...	18 Years -	University Medical Center Groningen
Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies	NCT04258566	Hepatocellular ...	Optical Molecul... Indocyanine Gre...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green	NCT01962649	Hepatocellular ...	ICG Optical molecul...	18 Years -	Massachusetts General Hospital
A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green	NCT01962649	Hepatocellular ...	ICG Optical molecul...	18 Years -	Massachusetts General Hospital

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