Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Neoplasm Metastasis

Nervous System Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Interventional arm

Control arm

Christian Senft, MD PhD

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure

The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.

Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.

Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection

Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection

Patient quality of life at 6 and 12 months following surgery is a secondary endpoint

Johann Wolfgang Goethe University Hospital

PD Dr. med. Christian Senft

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Mouth and Tooth Diseases

Uterine Cervical Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Prostatic Neoplasms

Stomach Neoplasms

Anorexia

Vomiting

Head and Neck Neoplasms

Sarcoma

Carcinoma, Renal Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Headache

Liver Neoplasms

Seizures

Sleepiness

Mesothelioma

Mesothelioma, Malignant

Mitral Valve Insufficiency

Kidney Neoplasms

Esophageal Neoplasms

Thymoma

Thymus Neoplasms

Tongue Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neoplastic Processes

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Adenocarcinoma

Adenoma

Neoplasms, Mesothelial

Thoracic Neoplasms

Esophageal Diseases

Lymphatic Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Tongue Cancer

Oral Cancer

Antineoplastic Agents

Bevacizumab

Temozolomide

Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.

QBS10072S targets cancers with high LAT1 expression.

QBS10072S

This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.

The dose escalation scheme for this trial employs an mTPI-2 design.

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S

A Phase 1, Open Label, Multi-Center, Single and Multiple Dose, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S in Previously Treated Patients With Advanced or Metastatic Cancers With High LAT1 Signatures, and in Patients With Relapsed or Refractory Grade 4 Astrocytoma

MTD will be determined by presence of AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Safety and tolerability will be determined by adverse events as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Determine the maximum plasma concentration of QBS10072S.

Determine the plasma concentration of QBS10072S over time.

Determine the half life of QBS10072S in plasma; the half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value.

Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.

Novotech (Australia) Pty Limited

Quadriga Biosciences, Inc.

tumor resection with intraoperative MRI-guidance

tumor resection with the use of an intraoperative MRI

intraoperative MRI-guided tumor resection

standard microsurgery

Christian Senft, M.D.

Volker Seifert, M.D.

Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.

Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved

Progression-free survival (radiological and/or clinical progression) at 6 months following surgery

Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI

Assessment of new postoperative deficits following tumor surgery

Goethe University

Neurosurgeon

Intraoperative MRI

Conventional Group

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Germany

Region of Enrollment

Dr. Christian Senft

Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery	NCT01798771	Primary Maligna... Glioma Glioblastoma Metastasis	Interventional ... Control arm	18 Years -	Johann Wolfgang Goethe University Hospital
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S	NCT04430842	Astrocytoma Brain Cancer Brain Metastase... Bladder Cancer Breast Cancer Cervical Cancer Cholangiocarcin... Colorectal Canc... Esophagus Cance... Gastric Cancer Head and Neck C... Kidney Cancer Liver Cancer Lung Cancer Melanoma Ovarian Cancer Pancreatic Canc... Pleural Mesothe... Prostate Cancer Sarcoma Tongue Cancer Thymic Carcinom... Urinary Tract C...	QBS10072S	18 Years -	Quadriga Biosciences, Inc.
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery	NCT01394692	Glioma	intraoperative ... standard micros...	18 Years -	Goethe University
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery	NCT01394692	Glioma	intraoperative ... standard micros...	18 Years -	Goethe University

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