Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after counseling

-\> Patients who after counseling decide for microsurgical resection of their brain metastasis

Patients over 18 years and under 90 years Patients with KPS ≥70 Patients with NSCLC, melanoma, breast cancer or renal cancer as primary tumor Maximum of three brain metastases on the diagnostic MRI Tumor volume of 8-20 ccm3 on the diagnostic MRI Lobular brain metastases Patients without any contraindications for both treatment options Written, signed informed consent for study particaption after study counseling

-\> Patients who after counseling decide for dose-staged radiosurgical treatment of their brain metastasis

Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.

Microsurgical resection

Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.

Gamma Knife radiosurgery

Josa Frischer, MD, PhD

Anna Cho, MD

Josa M Frischer, MD, PhD

Christian Dorfer, MD

Karl Rössler, MD

Barbara Kiesel, MD

Background. Brain metastases (BM) are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). In contrast to microsurgical resection, Gamma Knife radiosurgery (GKRS) is a non-invasive neurosurgical method, which allows treatment in multimorbid patients with contraindications for surgery in general anesthesia. Furthermore, stereotactic radiosurgery is the only local treatment method for multiple disseminated and thereby non-resectable brain metastases. In general, microsurgical resection is considered the treatment of choice for BM exceeding \>3 cm in diameter. However, since the establishment of the dose-staged technique, larger metastases can also be treated radiosurgically in selected patients. This novel method allows the application of high cumulative dose for the treatment of complex brain metastases.

Aim. The aim of the study is to evaluate the clinical outcome in brain metastases patients with tumor volume between 8 and 20 ccm3. The clinical outcome will be compared between surgically and radiosurgically treated BM patients.

Patients and methods. The investigators plan to conduct an explorative prospective study including about 50 radiosurgically and 50 surgically treated patients with brain metastases. If a patient fulfill study-relevant inclusion criteria at the time of BM diagnosis, the principle study investigator will offer both treatment options to the patient. Depending on patient's choice, he/she will be categorized either to surgical or to radiosurgical treatment group. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks since both treatments represent suitable therapy options.

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection - Evaluation of Neurosurgical Treatment Methods for Patients With Larger Brain Metastases - an Explorative Prospective Study

Time from first treatment until local tumor progression

Medical University of Vienna

Principal Investigator

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Transsphenoidal endoscopic resection of pituitary adenoma

Endoscopic resection

Transsphenoidal microsurgical resection of pituitary adenoma

Andrej Pala, MD

Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded

Endocrine Outcome of Surgery for Pituitary Adenoma

Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI

Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing.

Volumetric analysis of tumor volume before the surgery, intraoperatively and 3 months after surgery will be performed. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences

EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.

University of Ulm

fluorescence guided microsurgical resection (under 560 nm filter) in addition to the usual techniques, after iv injection of 200 mg (i.e. 3-4 mg/kg) of fluorescein sodium at the time of skin incision.

microsurgical resection with usual techniques

resection of cerebral metastases by microsurgery

microsurgical resection

Jean Francois OUDET

Marie Barba

Few studies have evaluated the use of fluorescein sodium for the resection of brain tumours (especially glioblastomas) but also cerebral metastases. We therefore propose to evaluate the technique of fluorescence guided microsurgery (fluorescein sodium) compared to the conventional microsurgical technique in the resection of cerebral metastases in adults in order to specify, by a prospective and randomised study, the assistance provided by this technique in the quality of resection and the gain in terms of overall survival and local control of brain disease.

Cerebral metastases are a major public health problem in cancer patients. They are the most common brain tumours in adults. It is estimated that approximately 20-40% of patients with primary malignant neoplasia will develop cerebral metastasis during the course of their illness. In addition, the incidence of brain metastases is increasing due, in particular, to the aging of the population, as well as to the improvement of the overall management of cancer patients (cytotoxic or targeted systemic treatment) and easier access to magnetic resonance imaging (MRI), which improves patient survival. The prognosis of patients with brain metastases is still poor and the median overall survival of these patients is of the order of a few months. Although the management of brain metastases is multidisciplinary, the benefit of surgery has been clearly demonstrated in the literature. Consequently, it is demonstrated that the quality of the tumour excision and in particular the carrying out of the complete excision of contrast enhancement on the MRI is correlated with improved overall survival (especially in case of single metastasis) and improved local control of the disease or progression-free survival, but also a better quality of life. It is therefore essential to perform the most complete excision possible while minimising the associated morbidity. For this purpose, various tools for surgical resection have been developed and are available, including intraoperative fluorescence guided surgery. Sodium fluorescein is a fluorochrome that accumulates, after intravenous injection, into vascularised tumour tissues and is revealed intraoperatively by a light source of suitable wavelength (560 nm) using a set of lenses included in the microscope. The resection is thus guided by this fluorescence, the complete disappearance of which will translate into a complete tumour resection. Its interest is twofold: to increase the percentage of complete tumour resection and to improve survival without recurrence and overall survival.Few studies have evaluated the use of fluorescein sodium for the resection of brain tumours (especially glioblastomas) but also cerebral metastases. If two studies on brain metastases showed a complete resection rate greater than 80% and a better rate of local control of brain disease, it is important to note that these studies were not randomised (with a control arm), they did not really prove the effectiveness of this technique under fluorescence, hence the need to set up a randomised study. We therefore propose to evaluate the technique of fluorescence guided microsurgery (fluorescein sodium) compared to the conventional microsurgical technique in the resection of cerebral metastases in adults in order to specify, by a prospective and randomised study, the assistance provided by this technique in the quality of resection and the gain in terms of overall survival and local control of brain disease.

Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study

Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study- Fluomet Study

To evaluate the quality of excision in both neurosurgical techniques, in terms of complete resection of cerebral metastases, objectified by the absence of quantifiable tumour residues on early postoperative MRI (before 48 hours) in both groups, evaluated by one of the neuroradiologists associated with the project.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection	NCT04857905	Brain Metastase...	Microsurgical r... Gamma Knife rad...	18 Years - 90 Years	Medical University of Vienna
Endocrine Outcome of Surgery for Pituitary Adenoma	NCT03515603	Pituitary Adeno...	Endoscopic rese... Microsurgical r...	18 Years -	University of Ulm
Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study	NCT04116801	Cerebral Metast... Fluorescence Gu...	microsurgical r...	18 Years - 85 Years	Ramsay Générale de Santé
Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study	NCT04116801	Cerebral Metast... Fluorescence Gu...	microsurgical r...	18 Years - 85 Years	Ramsay Générale de Santé
Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study	NCT04116801	Cerebral Metast... Fluorescence Gu...	microsurgical r...	18 Years - 85 Years	Ramsay Générale de Santé

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