Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Obesity

Lipoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

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Antiemetics

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Prednisolone

Methylprednisolone

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Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

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Adrenergic Agonists

Isoproterenol

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Hormone Antagonists

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Protective Agents

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Bronchodilator Agents

Anti-Asthmatic Agents

Sympathomimetics

Beta-adrenergic agonists and corticosteroid

Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.

Prednisolone synthetic cortisone and Isoproterenol together

Leanne Redman, Ph.D.

Frank Greenway, M.D.

The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which are benign fatty tumors.

Lipomas are benign, non-cancerous fatty tumors that occur under the skin and make a bump that can be easily felt and often seen. The current treatment for lipomas is surgery. Isoproterenol, a medication used for the treatment of asthma and approved for injection under the skin, is known to cause fat cells to give up their fat. The fat cells become resistant to isoproterenol with repeated use. Prednisolone, a synthetic cortisone medication used to treat immune problems like allergy and approved for injection under the skin, keeps the fat cells from becoming resistant to isoproterenol. It is not known, if the fat cells in lipomas act like other fat cells or if the combination of isoproterenol and prednisolone injections would shrink lipomas without surgery. This study is designed to test this possibility.

Subjects will have a screening visit, 2 microdialysis visits a week apart, 20 treatment visits 5 days per week for 4 weeks, and up to 12 follow-up visits a year after treatment visits. During screening, subjects will have a history, physical exam, blood testing, electrocardiogram and a pregnancy testing if female with reproductive capacity. The first microdialysis visit will consist of placing two microdialysis catheters under the skin after the area is numbed. One microdialysis catheter will be in the lipoma and the other under the skin 2 inches away. The microdialysis catheter will connect to a pump, isoproterenol will be infused and the amount of fat breakdown measured. One week later prednisolone will be injected into the lipoma and under the skin 2 inches away. The microdialysis visit will be repeated 24 hours later.

Treatment will consist of injecting the lipoma 5 days a week with a mixture of isoproterenol and prednisolone in the Pennington clinic as a diabetic would inject insulin. Each week the blood pressure, pulse and lipoma will be measured and subjects will be asked how they feel. At the end of the treatment period the physical examination, blood test and electrocardiogram will be repeated.

The insertion of the microdialysis probes under the skin into the fat tissue could be uncomfortable, but numbing medication will be injected first to prevent this problem. At higher doses, isoproterenol could lower blood pressure and increase pulse rate. This should not happen at the doses used, but blood pressure and pulse will be monitored throughout the study. Prednisolone, at higher doses, could decrease the body's production of cortisone. This should not happen at the doses being used, but cortisone in the body will be measured during the trial. Blood tests involve the discomfort of a needle going through the skin of the arm, possible bruising and rarely fainting or infection. Trained technicians and sterile needles will minimize these risks.

Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

Lipothera

Pennington Biomedical Research Center

Principal Investigator

Prednisolone and Isoproteronol

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

The single case that did not have an increase in lipoma volume showed variability which may have been because of a small lipoma making accurate measurement difficult.

Leanne Redman

The Average Percent Volume Reduction in the Lipoma.

The Number of Lipoma Increased in Volume.

The Number of Subjects Elected to Have the Lipoma Removed.

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma

Lymphoma

Adenocarcinoma

Facies

Soft Tissue Neoplasms

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

Surgical resection

Theo Ruers, MD

Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.

Primary Objective:

The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.

Secondary Objective:

During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Optical Detection of Peripheral Nerve Bundles During Surgery

In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study

Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

Philips Electronics Nederland B.V. acting through Philips CTO organization

Philips Healthcare

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas	NCT00624416	Lipoma	Prednisolone sy...	18 Years - 60 Years	Pennington Biomedical Research Center
Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas	NCT00624416	Lipoma	Prednisolone sy...	18 Years - 60 Years	Pennington Biomedical Research Center
Optical Detection of Peripheral Nerve Bundles During Surgery	NCT01731379	Malignant Lymph... Malignant Lymph... Malignant Lymph... Carcinoma of Pa... Colon Rectal Ca... Tumor of Soft T...	Surgical resect...	18 Years -	Philips Healthcare

Spots Global Cancer Trial Database for fat

Every month we try and update this database with for fat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fat

Every month we try and update this database with for fat cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.