Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected.

Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected.

Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

Blood collection and early detection testing

early detection test

Hongbo Guo, MD, Ph.D

Boyang Liu, MD

Hongbo Guo, MD,Ph.D

ASCEND-BRAIN is a prospective, observational study aimed at early-detection of intracranial tumors by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 358 participants including intracranial malignant tumors, patients with benign disorders of central nervous system and healthy participants.

AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors

Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study

Guangzhou Burning Rock Dx Co., Ltd.

Zhujiang Hospital

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Glioblastoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Immunologic Factors

* Assess Inflammation (PBR PET)
* Immunotherapy
* Assess Inflammation (PBR PET)

* Chemoradiation
* Assess inflammation (PBR PET)
* Follow Patients

PBR PET

Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms.

Cancer Immunotherapy

Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care.

Radiation and chemotherapy

Elizabeth Gerstner, MD

This research study is studying the changes in primary and metastatic brain tumor inflammation using positron emission tomography (PET) imaging using a radioactive substance called \[11C\] PBR28a, which is also known as peripheral benzodiazepine receptors (PBR), or PBR-PET.

This research study is a Pilot Study, which is the first time investigators are examining this study intervention. The purpose of a pilot study is to obtain the preliminary data needed to justify performing a larger clinical trial on the effectiveness of an investigational intervention.

Standard treatment for the subjects' disease includes chemoradiation and immunotherapy.

In PET scans, a radioactive substance is injected into the body. The scanning machine finds the radioactive substance, which tends to go to cancer cells and areas of inflammation. For the PET scans in this study, the investigators are using a radioactive substance called \[11C\]PBR28.

The investigators would like to see if this tracer can be used to detect changes in inflammation during tumor treatment. PBR-PET scans will be performed at screening before therapy and then several weeks/months after the start of therapy, depending on the type of therapy used. No diagnostic decisions or clinical treatment decisions will be made based on any results obtained from these PET scans, and there will be no change in care. The information from these studies may help the investigators design methods that could be used in larger studies to more completely understand the role of inflammation in the treatment of cancer.

A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy

The change in PBR uptake in arms cohorts A and B from baseline to the start of cycle 4 for metastatic melanoma patients or cycle 3 for glioblastoma patients. The 18-kDa translocator protein (TSPO) is a protein that is expressed in mitochondria and is particularly prominently expressed by activated microglia, infiltrating macrophages, and reactive astrocytes. Thus, it is a marker of neuro-inflammation. PBR28 is a second generation PET tracer that binds to TPSO. PBR28 uptake was quantified using the standardized uptake value (SUV), which is the ratio of activity per unit volume of the region of interest (ROI) compared to cerebellum. Higher values indicate increased uptake in the ROI.

The median PBR28 uptake as measured by positron emission tomography (PET) following chemo-radiation. The 18-kDa translocator protein (TSPO) is a protein that is expressed in mitochondria and is particularly prominently expressed by activated microglia, infiltrating macrophages, and reactive astrocytes. Thus, it is a marker of neuro-inflammation. PBR28 is a second generation PET tracer that binds to TPSO. PBR28 uptake was quantified using the standardized uptake value (SUV), which is the ratio of activity per unit volume of the region of interest (ROI) compared to cerebellum. Higher values indicate increased uptake in the ROI.

Massachusetts General Hospital

Principal Investigators

Adverse event data were not collected as a part of this trial

* Assess Inflammation (PBR PET)
* Immunotherapy
* Assess Inflammation (PBR PET)

PBR PET

Cancer Immunotherapy: Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms.

Metastatic Melanoma to the Brain (Cohort A)

Primary Brain Tumor (Cohort B)

* Chemoradiation
* Assess inflammation (PBR PET)
* Follow Patients

PBR PET

Radiation and chemotherapy: Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care.

Primary Brain Tumor (Cohort C)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Elizabeth Gerstner

Before immunotherapy

During immunotherapy

Only a baseline measurement was taken for the 1 patient in cohort A. Change in PBR was therefore not possible to calculate for that patient. PBR PET was only assessed once in cohort C and is reported separately.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors	NCT05679089	Intracranial Tu...	early detection...	40 Years - 75 Years	Zhujiang Hospital
A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy	NCT02431572	Intracranial Tu... Glioblastoma Melanoma	PBR PET Cancer Immunoth... Radiation and c...	18 Years -	Massachusetts General Hospital
AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors	NCT05679089	Intracranial Tu...	early detection...	40 Years - 75 Years	Zhujiang Hospital
A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy	NCT02431572	Intracranial Tu... Glioblastoma Melanoma	PBR PET Cancer Immunoth... Radiation and c...	18 Years -	Massachusetts General Hospital
A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy	NCT02431572	Intracranial Tu... Glioblastoma Melanoma	PBR PET Cancer Immunoth... Radiation and c...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for intracranial tumors