Neoplasms

All Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Hypoparathyroidism

Hypocalcemia

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Parathyroid Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

All Drugs and Chemicals

Parathyroid Hormone

Previous admitted patients who were given conventional thyroidectomy combined with central neck lymph node dissection, without intra-operative nodes identification were enrolled into control group.

Newly admitted patients,from august 2016 to august 2018, who were given thyroidectomy combined with central neck lymph node dissection, with intra-operative identification of suspicious lymph nodes or parathyroid glands were regarded as experimental group.Intraoperative identification method includes Diff-quik staining and PTH test assay. 200 participants were planed for enrollment.

After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.

Intraoperative identification method

Rui Ling, Prof.

Meiling Huang, MD

Rui Ling

Juliang Zhang, Doctor

During surgery, a fine needle puncture was proceeded when suspicious nodes was found by clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid glands identification. Post-operative pathology outcome was considered as golden standard.

In the experiment group, when suspicious parathyroid glands or lymph nodes were observed, a 22 G needle was applied for in situ puncture at a 45 degree angle. The needle was initially thrust into the gland for 0.2 mm, and then we advanced the needle for another 0.2mm while gently withdrawing the plunger of the syringe and maintaining negative pressure. At this point, there has parathyroid tissue been adsorbed in the needle. Repeat this process in two different directions to guarantee the simple volume.

When cell smears finished, the smears were fixed in stationary liquid within 2-4 seconds for 5-20 seconds, and then Diff-Quik (DQ) staining technique was proceeded for rapid identification using Diff-Quik staining kit according to the instruction. After the following Diff-quick staining for 30 seconds, we can make out parathyroid cells and lymph nodes under high power microscope.

In addition,PTH immunochromatographic assay kit can also be used for parathyroid glands detection. Using indicator paper to dip to the punctured tissue, the existance of parathyroid glands could be ensured.

HE (Hematoxylin and Eosin) staining was used for pathological verification of suspicious nodes found during surgery. The suspicious nodes occurred in surgery were isolated and fixed with 4% paraformaldehyde for 12 h, embedded in parafﬁn and cut into 3-µm serial sections. Corresponding sections were stained with hematoxylin (BASO Diagnostics Inc. Zhuhai) for 10 min at room temperature. Then, sections were washed with running water. Subsequently, sections were washed with Scott promote blue liquid for 1 min, 1% hydrochloric acid alcohol differentiation liquid for 20 s, and Scott promote blue liquid for 1 min. Then, sections were stained with eosin (BASO Diagnostics Inc. Zhuhai) for 30 s. Sections were washed with running water and sealed for observation. Finally, sections were observed by Image-Pro Plus 5.0 software (Media Cybernetics, Inc., Bethesda, MD, USA).

Intra-operative Rapid Identification of Lymph Node and Parathyroid

Intra-operative Rapid Identification of Lymph Node and Parathyroid by Fine Needle Puncture for Thyroid Carcinoma

Accuracy,sensitivity and specificity of intraoperative identification method

The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.

Record the identification time of this novel method and the whole operation time

Xijing Hospital

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Prostatic Neoplasms

Neoplasm Metastasis

Breast Neoplasms

Hyperparathyroidism

Hyperparathyroidism, Secondary

Bone Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Diseases

Bone Density Conservation Agents

Micronutrients

Vitamins

Hormones

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Zoledronic Acid

Denosumab

Calcifediol

Trace Elements

Vitamin D3

Calciferol

CTAP101 Capsules

This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.

This is a multi-center, open-label, repeat-dose study to evaluate the safety, efficacy, and tolerability of CTAP101 Capsules in subjects with bone metastases who are receiving ongoing therapy with denosumab or zoledronic acid. Following screening, approximately 12 eligible subjects with breast cancer and approximately 12 eligible subjects with prostate cancer, all of whom have metastases to bone and are undergoing treatment with anti-resorptive therapies, will receive CTAP101 Capsules at an initial daily oral dose of 30 μg (1 capsule) for 4 weeks. The daily dose may be increased in 30 μg (1 capsule) increments at 4-week intervals to a maximum of 300 μg or until serum calcium reaches \>10.3 mg/dL for two consecutive visits (dose escalation phase) at which time the subject will suspend dosing until serum calcium is ≤10.0 mg/dL and will directly enter a 12-week maintenance phase, resuming treatment at a reduced daily dose, followed by a 2-week follow-up period. Subjects reaching the maximum dose without serum calcium reaching \>10.3 mg/dL, will directly enter the 12-week maintenance phase, followed by a 2-week follow-up period. Serum markers for monitoring bone metabolism (including plasma iPTH, PTHrP, and serum free calcifediol), immune function and tumor burden will be measured during the treatment period. The FACT-BP Quality of Life Measurement in Patients with Bone Pain questionnaire will be used to explore the effect of the treatment, if any, on musculoskeletal pain. The genotype of vitamin D binding protein (DBP) will also be determined. Safety will be monitored through adverse events, serum and urine chemistries, hematology, and ECGs.

Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid

Effect of CTAP101 Capsules on Serum Calcium, Plasma Intact Parathyroid Hormone and Vitamin D Metabolites in Patients With Advanced Breast or Prostate Carcinomas With Metastases to Bone and Receiving Ongoing Therapy With Denosumab or Zoledronic Acid

Measured by the number of participants with treatment related adverse events and abnormal physical examinations, vital signs, clinical laboratory tests (hematology, coagulation, and clinical chemistry, urine calcium, albumin and creatinine), and 12-lead ECG.

OPKO Health, Inc.

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Primary Hyperparathyroidism

Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.

Far Infrared Radiation

Ken Nedd, M.D.

Kwasi Donyina, Ph.D.

A study to determine the possibility of using far infrared radiation to treat Hyperparathyroidism.

Overactive parathyroid glands secrete an excess of parathyroid hormones, resulting in increased levels of calcium in the blood stream, which can lead to weakening of the bones and to kidney stones.

We are postulating that the non-invasive energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to stop the over secretion of the parathyroid hormones and normalize the body's metabolic functions.

Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism

Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism.

GAAD Medical Research Institute Inc.

Dr. Kwasi Donyina/Founder and President

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-operative Rapid Identification of Lymph Node and Parathyroid	NCT03268785	Thyroid Cancer Parathyroid; Ab... Hypocalcemia Hypoparathyroid...	Intraoperative ...	18 Years - 60 Years	Xijing Hospital
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid	NCT02274623	Breast Cancer Prostate Cancer Bone Neoplasms Hypocalcemia Hyperparathyroi...	CTAP101 Capsule...	18 Years -	OPKO Health, Inc.
Intra-operative Rapid Identification of Lymph Node and Parathyroid	NCT03268785	Thyroid Cancer Parathyroid; Ab... Hypocalcemia Hypoparathyroid...	Intraoperative ...	18 Years - 60 Years	Xijing Hospital
Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism	NCT00573573	Hyperparathyroi...	Far Infrared Ra...	-	GAAD Medical Research Institute Inc.

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