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This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Radioactive drugs, such as 177Lu-DOTATATE, may carry radiation directly to cancer cells and not harm normal cells. 177Lu-DOTATATE may help to control endocrine cancers compared to standard treatment.
I. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by Ia. Computed tomography (CT) or Ib. Magnetic resonance imaging (MRI).
I. To estimate progression-free survival at 1-year. II. To correlate blood pressure control and change/discontinuation of antihypertensive medications with tumor responses in patients with pheochromocytomas and paragangliomas (PHPGs).
III. To correlate plasma metanephrines and chromogranin A with tumor responses in patients with PHPGs.
IV. To correlate calcitonin, carcinoembryonic antigen, and chromogranin A with tumor responses in patients with medullary thyroid carcinoma (MTCs).
V. To correlate pituitary hormones (depending on particular tumor, e.g. prolactin for prolactinomas, insulin-like growth factor (IGF-1) for acromegaly, adrenocorticotropic hormone (ACTH) and 24-hour urine free cortisol for Cushing disease, and chromogranin A with tumor responses in patients with functional pituitary carcinomas).
VI. To correlate calcium, intact parathyroid hormone (iPTH), and chromogranin A with tumor responses in patients with parathyroid carcinoma.
VII. Toxicity assessment by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0).
VIII. To correlate tumor responses with tumor uptake score in somatostatin receptor scintigraphy, overall prognosis and responsiveness to lutetium Lu 177 dotatate (177Lu-DOTATATE).
IX. To determine the percentage of tumors that demonstrate uptake on diagnostic 68Gallium-DOTATATE positron emission tomography (PET)/CT that would make treatment with 177Lu-DOTATATE feasible.
I. To evaluate pituitary function in all patients to look for possible radiation late effects on the pituitary gland.
II. To estimate best biochemical response for specific tumor markers in patients with non-measurable disease.
III. To correlate biochemical response in patients with non-measurable disease with RECIST 1.1 tumor response criteria for patients with non-measurable disease.
Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at week 72 and then every 24 weeks for up to 5 years.
Locally Advanced Adrenal Gland Pheochromocytoma
Lutetium Lu 177 Dotatate
M D Anderson Cancer Center
Not yet recruiting
M.D. Anderson Cancer Center
Published on BioPortfolio: 2019-10-02T07:21:31-0400
The objective is to investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objecti...
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin re...
- According to Martin F et al, AKT is highly phosphorylated in phenochromocytoma but not in benign adrenocortical tumors. - In nonfunctioning carcinoid, the PI3K/AKT/mTOR pathway...
This is a non-randomized phase II , open label, comparative study. Patients with advanced non-resectable and/or progressive gastro-entero-pancreatic Neuroendocrine Tumours - GEP-NET, (G1, ...
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones ca...
Background The aim of this study was to compare the adrenal gland size of fetuses of women with gestational diabetes mellitus (GDM) with that of healthy control fetuses. Methods This prospective cross...
We performed 18F-FDG PET/CT scan to assess the SUVmax values in the different adrenal masses including Cushing syndrome, pheochromocytoma, primary hyperaldosteronism and nonfunctional adrenal adenomas...
Pheochromocytoma crisis is an exceptional consequence of the release of storage vesicles of the adrenal medulla. It is complicated by fulminant adrenergic myocarditis. It offers a unique opportunity t...
To evaluate the safety and clinical effectiveness of computed tomography (CT)-guided cryoablation for adrenal pheochromocytoma (AP).
Broadening horizons with Ac-DOTATATE targeted alpha therapy for gastroenteropancreatic neuroendocrine tumour patients stable or refractory to Lu-DOTATATE PRRT: first clinical experience on the efficacy and safety.
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A neural crest tumor usually derived from the chromoreceptor tissue of a paraganglion, such as the carotid body, or medulla of the adrenal gland (usually called a chromaffinoma or pheochromocytoma). It is more common in women than in men. (Stedman, 25th ed; from Segen, Dictionary of Modern Medicine, 1992)
Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.
The inner portion of the adrenal gland. Derived from ECTODERM, adrenal medulla consists mainly of CHROMAFFIN CELLS that produces and stores a number of NEUROTRANSMITTERS, mainly adrenaline (EPINEPHRINE) and NOREPINEPHRINE. The activity of the adrenal medulla is regulated by the SYMPATHETIC NERVOUS SYSTEM.
A pair of glands located at the cranial pole of each of the two KIDNEYS. Each adrenal gland is composed of two distinct endocrine tissues with separate embryonic origins, the ADRENAL CORTEX producing STEROIDS and the ADRENAL MEDULLA producing NEUROTRANSMITTERS.
19-Iodocholest-5-en-3 beta-ol. A cholesterol derivative usually substituted with radioactive iodine in the 19 position. The compound is an adrenal cortex scanning agent used in the assessment of patients suspected of having Cushing's syndrome, hyperaldosteronism, pheochromocytoma and adrenal remnants following total adrenalectomy.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...