Musculoskeletal Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Bone Diseases

Neovascularization, Pathologic

Bone Neoplasms

Skull Base Neoplasms

Skull Neoplasms

Metaplasia

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.

Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.

near-infrared light nasal endoscope used with ICG

Daniel Prevedello, MD

This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.

Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery

We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance.

Ohio State University

Associate Professor

Adverse events were only recorded if the event was related to the study procedure. Events that occur due to the standard of care surgery were not recorded.

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.

near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.

Near-infrared Light Nasal Endoscope Used With ICG

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Daniel Prevedello, MD

gland to internal carotid artery ratio

tumor to internal carotid artery ratio

Patients undergoing tumor resection via endoscopic endonasal approach. Tumor pathologies included: pituitary adenoma (10), chordoma (4), tuberculum sellae meningioma (3), chondrosarcoma (1) estesioneuroblastoma (1) and Rathke's cleft cyst (1)

ICG Fluorescence Ratio

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

Aromatase Inhibitors

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months

1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months

Placebo

The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown.

In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.

Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients

Universitaire Ziekenhuizen KU Leuven

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery	NCT03072186	Skull Base Neop... Skull Neoplasms Bone Neoplasm Neoplasms Bone Diseases Musculoskeletal...	near-infrared l...	18 Years -	Ohio State University
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery	NCT03072186	Skull Base Neop... Skull Neoplasms Bone Neoplasm Neoplasms Bone Diseases Musculoskeletal...	near-infrared l...	18 Years -	Ohio State University
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients	NCT01809171	Breast Cancer Musculoskeletal...	Vitamin D3 Placebo	18 Years -	Universitaire Ziekenhuizen KU Leuven

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