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Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease Progression?

Study Purpose

PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details will be performed on set intervals to patients with brain tumor & brain metastases in order to try to optimize the study protocol, distinguish between pseudo-response to anti-angiogenic therapy and tumor progression, and most importantly try to distinguish between progressive tumor and treatment related effects.3 cohort of patients will be included in the study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject with glial brain tumors, - Subjects with metastatic brain tumors that were treated with stereotactic radiation (SRS), * Subjects with metastatic brain tumors which were not treated.

Exclusion Criteria:

  • - glial tumor with no histological diagnosis.
  • - non breast of lung metastasis.
  • - non compliance.
  • - unable to lay still during the scanning.
  • - mri non.
  • - renal failure/gadolinium sensitivity.
  • - less than 5 mm metastatic tumors.
  • - bleeding brain tumors.
- pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03068520
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assuta Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michal Guindy, MD
Principal Investigator Affiliation Assuta Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor
Additional Details

The multimodality approach for management of primary and secondary brain tumors includes surgery, radiotherapy and chemotherapy. Determination of an objective response to treatment relies on imaging findings (e.g. CT, MRI, PET).During the course of the disease patients with brain tumors often develop new or worsening contrast-enhancing lesions on routine follow-up imaging.These lesions may reflect tumor recurrence, treatment effect, or a combination of both. Discerning between tumor recurrence and treatment effect is clinically significant issue and a major challenge in neuro-oncology. Treatment-related effects exist within a spectrum, with "pseudoprogression" reflecting subacute and often transient injury, and "radiation necrosis" reflecting later and more permanent damage.The difficulty in differentiating tumor progression from treatment-related effects has serious implications for individual patient treatment decisions and prognosis as well as for clinical trial design and interpretation of results. A contemporary hybrid scanner technology is capable of acquiring both metabolic information from PET and morphological and functional details from MRI. This new integrated technique opens new horizons for clinical and research evaluation of brain tumors and the associated treatment effects. The aim of the current study is to use the combined data obtained by PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details in order to: 1. Distinguish between progressive tumor and treatment related effects. 2. To identify pseudo-response to antiangiogenic therapy from tumor progression. 3. To optimize the study protocol of PET-MRI for future routine clinical application. The study will include three cohorts of patients with brain tumors: 1. Primary brain tumors: A cohort of 60 adult patients (age: 18-70) with newly diagnosed high grade gliomas (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma) scheduled for a combined treatment with chemotherapy and radiotherapy. Patients will be eligible for the study immediately after receiving the pathological diagnosis and prior to any further treatment. These patients will undergo the PET-MRI scanning at 4 time points as follows:

  • - 1st scan: after surgery or biopsy and before any further treatment.
  • - 2nd scan: will be performed up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen.
  • - 3rd and 4th scans: will follow with interval of 3 months between studies.
  • - Additional scans will be performed by the decision of the investigators or when the patient is scheduled for antiangiogenic therapy.
2. Brain metastases treated with stereotactic radiosurgery (SRS): A cohort of 60 adult patients (age: 18-75) who are being followed after SRS treatment for brain metastases secondary to breast or lung cancer whose recent imaging showed signs of progression in at list one of the previously treated lesion. Progression will be determined by Response Assessment in Neuro-Oncology Criteria (RANO criteria) for brain metastases. Number of target lesions should not exceed 4 with size of lesions ranging between 5-40 mm. These patients will undergo the PET-MRI scanning at three time points as follows:
  • - 1st scan: Following determination of progression of SRS treated lesion based on standard surveillance MRI.
  • - 2nd and 3rd scans: will be performed every 2 months after the first scan.
  • - Additional scans will be performed by the decision of the investigators.
3. Brain metastases not treated with SRS/radiotherapy.A cohort of 20 adult patients (age: 18-75) with a diagnosis of brain metastases secondary to human epidermal growth factor receptor 2 (HER2) positive breast cancer or anaplastic lymphoma kinase (ALK) or Epidermal Growth Factor Receptor (EGFR) gene mutant lung cancer who might be candidate for SRS treatment and in whom targeted therapy is selected instead. The size of the lesions should range between 5-40 mm. These patients will undergo the PET-MRI scanning at three time points as follows:
  • - 1st scan: after the first documentation of brain metastases on standard MRI.
  • - 2nd and 3rd scans: will be performed every 2 months after the first scan.
  • - In case of progression and SRS treatment follow-up scanning will be performed every 2 months.
- Additional scans will be performed by the decision of the investigators

Arms & Interventions

Arms

Other: PRIMARY BRAIN TUMOR (PBT)

patients with PBT (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma), before treatment with radiation and chemotherapy.will be followed with PET MRI

Other: METASTATIC BT TREATED BY SRS

patients with lung or breast metastasis to brain treated by SRS in which at least one lesion showed deterioration by MR performed after treatment. will be followed with PET MRI

Other: METASTATIC BT NOT TREATED BY SRS

patients with lung or breast metastasis to brain where the SRS treatment was postponed for clinical reasons (getting mutation information for targeted treatment) the lesion size measures 5-40 mm. will be followed with PET MRI

Interventions

Diagnostic Test: - PET MR

PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Assuta Medical Centers, Tel Aviv, Israel

Status

Recruiting

Address

Assuta Medical Centers

Tel Aviv, ,

Site Contact

Judith LuKman, MD

[email protected]@assuta.co.il

972-544858197