Neoplasms

All Conditions

Rare Diseases

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Fluorodeoxyglucose F18

Patients will be divided in two groups for statistical analysis:

* patients with detectable BAT by PET-CT (BAT+)
* patients with no detectable BAT by PET-CT (BAT-)

measurement of temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test

Infrared themrography

Françoise Latil-Plat

Patients affected by pheochromocytoma (PHEO) have brown-adipose tissue (BAT) hyperactivation. They perform, in routine settings, a FDG PET-CT scan. The high metabolic activity of BAT and its ability to consume both glucose and fatty acid suggest that it may have potential as a therapeutic target in the treatment of obesity. However, alternative non-invasive techniques to PET-CT BAT detection still need more validation. Accordingly, our aim will be to measure the temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.

Objectives and Methodology:

* To analyse the change in temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.
* To check the decreased temperature and microcirculatory response after a cold test following resection of the tumor

All the patients affected by will benefit from a:

* clinical: treatments
* biological evaluations: glycemia, triglycerides, total cholesterol, HDL-C, LDL-C, plasma epinephrine and norepinephrine, urine catecholamine
* cutaneous microcirculation by means of Laser Speckle Imaging will be recorded at rest and during a cold test in the supra-clavicular region
* cutaneous microcirculation by means of Laser Doppler Flowmetry will be recorded at rest and during a cold test with one probe in the supra-clavicular region and one probe in umbilical region
* skin temperature by means of infrared thermography will be recorded at rest and during a cold test in the supra-clavicular region

Patients who will have surgery will be investigated before and after one year following resection of the tumor.

Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (MICROBAT)

Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue: Proof of Concept Against PET-CT in Patients Affected by Pheochomocytoma and/or Paraganglioma

Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) in basal condition

Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) during a cold test (feet in water at 19°C during 20min)

Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) in basal condition

Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) during a cold test (feet in water at 19°C during 20min)

18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..

18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer..

∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0)

∆ diff PU = diff PU (month12) - diff PU (day0)

Centre Hospitalier Henri Duffaut - Avignon

Assistance Publique Hopitaux De Marseille

University of Avignon

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms, Vascular Tissue

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Propranolol

Timolol

Maleic acid

Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.

One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.

No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.

Marty O Visscher, PhD

Denise Adams, MD

Adrienne Hammill, MD, PhD

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas

IH height and volume will be obtained from surface scans with the Artec scanner with a 0.5 mm resolution, 0.1 mm accuracy, at 60 cm. Three dimensional scans will be created with the Artec Studio software and features quantified with the three dimensional software. Soft tissue landmarks will create the region of interest for all evaluations. Height and volume will be calculated for the infantile hemangioma versus the control.

Temperature information will be acquired with a thermal imaging camera with analysis software. The thermal features of the surrounding uninvolved control skin are removed by applying thresholds. Static infrared thermography captures the steady-state condition and spatial distribution. Dynamic infrared thermography applies a stress (cooling) to stimulate the thermal response within the tissue.

High resolution color Images will be taken taken with a digital camera, Micro 60 mm lens with a wireless close up flash system at 30cm and perpendicular to the site. The images are color corrected and processed into three distinct images : red color, blue-yellow color, and lightness (white - back).

Color and thermal images are co-registered and analyzed with customized software. The system creates quantitative outputs and maps for visualization of IH regions of thermal and color activity. Threshold values for the lightness, red color, blue color and thermal images are selected based upon histogram distributions of the uninvolved skin as the values above the mean and multiple standard deviations The pixels beyond the thresholds are used to quantify and map the features due to the hemangioma itself.

Tissue mechanical properties (i.e., elasticity, elastic deformation, laxity, stiffness, etc.) will be measured to assess tissue deformability. The instrument measures biomechanical properties of the skin by applying a negative pressure, in the range between 20 and 500 mbar. These properies are compared to an uninvolved contralateral control site.

Society for Pediatric Dermatology

Children's Hospital Medical Center, Cincinnati

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Esophageal Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Colorectal Neoplasms

Breast Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Esophageal Diseases

Esophageal Cancer

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Tongue Cancer

Herbal and Botanical

Radiopharmaceuticals

Cola

18F-fluoromisonidazole

fluorescence angiography

laboratory biomarker analysis

infrared thermography

magnetic resonance imaging

therapeutic conventional surgery

[18F]-ML-10

fludeoxyglucose F 18

rubidium Rb-82

Contact Person

Peter Ell, MD

RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.

PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.

OBJECTIVES:

* To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
* To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.

OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.

Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or \[18F\]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.

After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.

Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer

Tumor Angiogenesis in Non-Small Cell Lung (NSCLC), Colorectal, Breast, Esophageal, Head and Neck Cancer: Radiology-Pathology and Prognostic Correlation

University College London (UCL) Cancer Institute

Antineoplastic Agents

Trastuzumab

Estrogens

HER2-positive (HER2+) and Estrogen receptor-positive (ER+) breast cancer patients undergoing adjuvant chemotherapy including trastuzumab.

HER2-negative breast cancer patients (HER2-) and Estrogen receptor-positive (ER+) breast cancer patients undergoing adjuvant chemotherapy without trastuzumab.

Both groups recieve standard care as decided by the responsible clinicians at the department of Oncology. The course of the treatment is completely independent from the observations in the present study.

None (Observational study)

Tora Ida Henriksen, MSc., Ph.D.

Laura Thomsen, MSc.

Søren Nielsen, MSc., Ph.D.

The objective of this observational study is to investigate the significance of the HER2 receptor for brown fat activity in humans. Our preliminary data clearly demonstrates that the ErbB signaling pathway, which includes the HER2 receptor, strongly promotes development and function of cultured human BAT cells. The HER2 receptor is a part of the ErbB signaling pathway, and antibodies against thee HER2 receptor are a part of the standard treatment for HER2-positive breast cancer. Therefore, the hypothesis is that the activity of brown fat will be reduced in patients treated with HER2 blocking antibody compared to patients who are not treated with HER2 blocking antibody. The present study simply takes advantage of the treatment protocol to explore the contribution of the HER2 receptor in the development of brown adipose tissue in humans. Participants will complete two testing days, one before and one after their treatment period of approx. one year. On the testing days, identification of brown fat activity will be performed using cooling and infrared thermography. In addition, resting metabolic rate and a glucose tolerance test will be performed. Since presence of active brown adipose tissue in humans is inversely related to obesity, total and visceral fat mass, plasma glucose levels, presence of cardiovascular disease and diabetes status, it is of great importance to investigate the molecular mechanisms for development of brown fat tissue and may lead to discovery of novel strategies to counteract obesity and obesity related disorders.

BACKGROUND:

Breast cancer is the most common cancer among women worldwide, and with increasing survival rates focus on long-term adverse effects of treatment has increased. Weight gain is well documented and common occurrence for many breast cancer patients. Recently, a review reported that 50-96% of women experience weight gain during treatment. Furthermore, many patients report a progressive weight gain in the months and years after treatment and patients rarely return to their pre-diagnosis weight. Moreover, weight gain in breast cancer patients has been linked to a poor prognosis compared to patients without weight gain, and to obesity-related disorders including metabolic syndrome.

Adipose tissue is one of the largest human organs. Two functionally distinct types of adipose tissue exist: white adipose tissue and brown adipose tissue (BAT). While BAT was long thought to be present only in rodents and human infants, it is now clear that active BAT also exists in varying degrees in adult humans. Activated BAT has great capacity for energy consumption and takes up large amounts of blood lipids and glucose to use in thermogenesis, and the presence of active BAT in humans is inversely related to obesity, total and visceral fat mass, plasma glucose levels, presence of cardiovascular disease and diabetes status. In accordance, acute cooling increases energy expenditure compared to thermoneutral conditions and correlates with higher BAT activity. Finding ways to activate BAT in humans is thus an attractive approach to prevent weight gain and ensuing comorbidities.

Human epidermal growth factor receptor 2 (HER2) positive breast cancer accounts for \~15 % of breast cancer cases, and direct inhibition of the HER2 receptor (also called the ErbB2 receptor) is used as standard treatment of HER2-positive breast cancer.

Our preliminary data clearly demonstrates that the ErbB signaling pathway, which includes the HER2 receptor, strongly promotes development and function of cultured human BAT cells and mouse brown adipose tissue. A potential secondary effect of the HER2 receptor blockade used in cancer treatment, is the binding of these inhibitors to ErbB2 receptors in the adipose tissue subsequently affecting downstream signaling pathways that might influence the activity of brown adipose tissue and thereby whole-body metabolism. In support of this hypothesis, weight gain during chemotherapy in HER2-positive breast cancer patients is associated with a decrease in the activity of brown adipose tissue.

Since BAT activity has been suggested as a target to limit weight gain and metabolic disorders, it is of great importance to understand the molecular mechanisms behind BAT recruitment and function in humans. This study will provide insight into the contribution of the HER2 receptor in the development of brown adipose tissue in humans and may thus lead to discovery of novel strategies to counteract obesity and obesity related disorders in breast cancer survivors as well as in the general population.

STUDY SET-UP

Against this background, a prospective cohort study will be performed at the Centre for Physical Activity (CFAS), and the Department of Oncology, both located at Rigshospitalet, Copenhagen, Denmark. A total of 30 patients will be recruited. This includes patients with breast cancer HER2+/ Estrogen receptor (ER)+ treated with the recombinant monoclonal anti-neoplastic antibody combination trastuzumab (n = 15) and BMI and age-matched HER2-/ER+ patients with breast cancer, who are not treated with ErbB2/HER2 receptor blockage, will be used as a control group (n = 15). The treatment is planned and initiated according to standard of care and for clinical reasons. The present study simply takes advantage of the treatment protocol to explore a physiological mechanism, hence participation in the study does not affect the treatment regimen. After cessation of the study period subjects will continue their treatment as prescribed by the oncologists prior to study enrolment.

Patients included in the study will undergo two identical test days; one prior to the treatment and one by the end of the treatment. The study does not include any additional interventions, restrictions, or investigations during the treatment period. For each testing day, the participants will be assessed for body composition (DXA scan) and anthropometrics. This will be followed by a cooling protocol to activate the brown adipose tissue. BAT activity will be measured by infrared thermography. Furthermore, participants will undergo measurements of resting metabolic rate, an oral glucose tolerance (OGTT) test and blood samples.

Provided that the patient fulfilled the inclusion criterion concerning cold activated BAT (see inclusion criteria), they will be invited to a second test day after adjuvant treatment. This test day will be similar to the first, i.e., including anthropometric measurements, a DXA scan, blood samples, an OGTT, indirect calorimetry measurements, a cooling intervention and IRT assessment of BAT activity.

AIM

The objective of this project is thus to investigate the effects of HER2 blockade on human brown adipose tissue activity in HER2+ breast cancer patients as well as associated metabolic parameters.

Secondarily, the study aim to investigate whether a decrease in BAT activity is associated with weight gain or increased fat mass (as assessed by DXA-scan), decreased metabolic rate and changes in metabolic parameters including glycemic control in patients treated with HER2 blocking antibodies.

HYPOTHESIS

The hypothesis is that the activity of brown fat will be reduced in patients treated with HER2 blocking antibody trastuzumab for 17 series amounting to approx. one year of treatment compared to patients who are not treated with trastuzumab.

We will draw blood samples, but not for genetic analysis

The Effects of HER2 Receptor Signaling on Human Brown Fat Activity

The Effects of HER2 Receptor Signaling on Human Brown Fat Activity: A 1-year Prospective Cohort Study in Trastuzumab-treated Breast Cancer Patients Versus HER2 Negative Controls

Difference in cold-induced BAT activity between HER2+ breast cancer patients and HER2- breast cancer controls measured with infrared thermography (temperature difference).

Difference in weight (kilograms) between the HER2+ positive subjects and the HER2 negative controls

Difference in fat mass (kilograms) between the HER2+ positive subjects and the HER2 negative controls

Difference in resting- and cold induced energy expenditure (calories/day) between the HER2+ positive subjects and the HER2 negative controls, by measuring oxygen consumption (VO2) and carbon dioxide production (VCO2) (Indirect calorimetry).

Difference in cold induced energy expenditure (calories/day) between the HER2+ positive subjects and the HER2 negative controls, by measuring oxygen consumption (VO2) and carbon dioxide production (VCO2) (Indirect calorimetry).

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring insulin (pmol/L)

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring glucose (mmol/L).

Difference in glycemic control between the HER2+ positive subjects and the HER2 negative controls. Examined by an Oral Glucose Tolerance Test measuring C-peptide (nmol/L).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (MICROBAT)	NCT04605848	Pheochromocytom... Paraganglioma	Infrared themro...	18 Years - 75 Years	University of Avignon
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati
Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer	NCT01254591	Breast Cancer Colorectal Canc... Esophageal Canc... Head and Neck C... Lung Cancer	18F-fluoromison... fluorescence an... laboratory biom... infrared thermo... magnetic resona... therapeutic con... [18F]-ML-10 fludeoxyglucose... rubidium Rb-82	-	National Cancer Institute (NCI)
The Effects of HER2 Receptor Signaling on Human Brown Fat Activity	NCT06222957	Breast Cancer	None (Observati...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for infrared thermography