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

This study is currently recruiting participants.
Verified March 2017 by Michal Guindy, Assuta Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03068520
First Posted: March 3, 2017
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Michal Guindy, Assuta Medical Center
  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.

Condition Intervention
Brain Tumor Diagnostic Test: PET MR

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

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 pseudoresponse to antiangiogenic therapy from tumor progression
  3. To optimize the study protocol of PET-MRI for future routine clinical application.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging After Stereotactic Radiosurgery for Brain Metastases or Primary Tumor Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease ?

Further study details as provided by Michal Guindy, Assuta Medical Center:

Primary Outcome Measures:
  • Distinguish between progressive tumor and treatment related effects [ Time Frame: 1st scan: after surgery or biopsy and before any further treatment - 2nd scan: up to 4 weeks after completing the combined radiotherapy and chemotherapy regimen. - 3rd and 4th scans - 3 month interval apart ]
    finding PET-MRI difference between progression and treatment effect correlating with clinical out come


Estimated Enrollment: 140
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Diagnostic Test: PET MR
PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals
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

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

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068520


Contacts
Contact: Michal Guindy, MD 972-50-8800102 micahlgu@assuta.co.il
Contact: Judith Luckman, MD 972-54-4858197 judithl@assuta.co.il

Locations
Israel
Assuta Medical Centers Recruiting
Tel Aviv, Israel
Contact: Judith LuKman, MD    972-544858197    Gudithl@assuta.co.il@assuta.co.il   
Contact: Michal Guindy, MD    972-50-8800102    michalgu@assuta.co.il   
Sponsors and Collaborators
Assuta Medical Center
Rabin Medical Center
Investigators
Principal Investigator: Michal Guindy, MD Assuta Medical Center
  More Information

Publications:

Responsible Party: Michal Guindy, Medical Director of Imaging Services, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT03068520     History of Changes
Other Study ID Numbers: 022-16-ASMC
First Submitted: February 20, 2017
First Posted: March 3, 2017
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michal Guindy, Assuta Medical Center:
PET
MRI
BRAIN METASTASIS
BRAIN PRIMARY TUMOR
RESPONSE TO TREATMENT