Brain TumorNCT03068520
Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease Progression?
A study testing PET MR in people with Brain Tumor, run by Assuta Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- PET MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- less than 5 mm metastatic tumors
- bleeding brain tumors
- pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assuta Medical Centers
Tel Aviv
Judith LuKman, MD, 972-544858197, Gudithl@assuta.co.il@assuta.co.il
Michal Guindy, MD, 972-50-8800102, michalgu@assuta.co.il
About this study
Official title: Imaging After Stereotactic Radiosurgery for Brain Metastases or Primary Tumor Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease ?
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.
Read the detailed description
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:
- Distinguish between progressive tumor and treatment related effects
- To identify pseudo-response to antiangiogenic therapy from tumor progression
- To optimize the study protocol of PET-MRI for future routine clinical application.
The study will include three cohorts of patients with brain tumors:
- 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
- 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
- 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
- Conditions
- Brain Tumor
- Being tested
- PET MR
- Keywords
- PET, MRI, BRAIN METASTASIS, BRAIN PRIMARY TUMOR, RESPONSE TO TREATMENT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET MRDiagnostic test
PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals
| Study group | Role | What they receive |
|---|---|---|
| PRIMARY BRAIN TUMOR (PBT) | Other | patients with PBT (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma), before treatment with radiation and chemotherapy.will be followed with PET MRI Receives: Diagnostic Test: PET MR |
| METASTATIC BT TREATED BY SRS | Other | 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 Receives: Diagnostic Test: PET MR |
| METASTATIC BT NOT TREATED BY SRS | Other | 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 Receives: Diagnostic Test: PET MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distinguish between progressive tumor and treatment related effects
finding PET-MRI difference between progression and treatment effect correlating with clinical out come
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rabin Medical Center
- Responsible party
- Principal investigator, Michal Guindy, Assuta Medical Center
- Investigators
- Michal Guindy, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068520
- Sponsor's protocol ID
- 022-16-ASMC
- Status last verified
- Mar 2017
- First submitted
- 20 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horky LL, Treves ST. PET and SPECT in brain tumors and epilepsy. Neurosurg Clin N Am. 2011 Apr;22(2):169-84, viii. doi: 10.1016/j.nec.2010.12.003.
PubMed 21435569Chen W, Silverman DH, Delaloye S, Czernin J, Kamdar N, Pope W, Satyamurthy N, Schiepers C, Cloughesy T. 18F-FDOPA PET imaging of brain tumors: comparison study with 18F-FDG PET and evaluation of diagnostic accuracy. J Nucl Med. 2006 Jun;47(6):904-11.
PubMed 16741298Momose T, Nariai T, Kawabe T, Inaji M, Tanaka Y, Watanabe S, Maehara T, Oda K, Ishii K, Ishiwata K, Yamamoto M. Clinical benefit of 11C methionine PET imaging as a planning modality for radiosurgery of previously irradiated recurrent brain metastases. Clin Nucl Med. 2014 Nov;39(11):939-43. doi: 10.1097/RLU.0000000000000561.
PubMed 25140562Nanni C, Fanti S, Rubello D. 18F-DOPA PET and PET/CT. J Nucl Med. 2007 Oct;48(10):1577-9. doi: 10.2967/jnumed.107.041947. No abstract available.
PubMed 17909255Verma N, Cowperthwaite MC, Burnett MG, Markey MK. Differentiating tumor recurrence from treatment necrosis: a review of neuro-oncologic imaging strategies. Neuro Oncol. 2013 May;15(5):515-34. doi: 10.1093/neuonc/nos307. Epub 2013 Jan 16.
PubMed 23325863Tudisca C, Nasoodi A, Fraioli F. PET-MRI: clinical application of the new hybrid technology. Nucl Med Commun. 2015 Jul;36(7):666-78. doi: 10.1097/MNM.0000000000000312.
PubMed 25830717Kondziolka D, Patel A, Lunsford LD, Kassam A, Flickinger JC. Stereotactic radiosurgery plus whole brain radiotherapy versus radiotherapy alone for patients with multiple brain metastases. Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):427-34. doi: 10.1016/s0360-3016(99)00198-4.
PubMed 10487566Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
PubMed 16757720Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8.
PubMed 15158627Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.
PubMed 19801201Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
PubMed 21041710Sahgal A. Point/Counterpoint: Stereotactic radiosurgery without whole-brain radiation for patients with a limited number of brain metastases: the current standard of care? Neuro Oncol. 2015 Jul;17(7):916-8. doi: 10.1093/neuonc/nov087. No abstract available.
PubMed 26092877Patel TR, McHugh BJ, Bi WL, Minja FJ, Knisely JP, Chiang VL. A comprehensive review of MR imaging changes following radiosurgery to 500 brain metastases. AJNR Am J Neuroradiol. 2011 Nov-Dec;32(10):1885-92. doi: 10.3174/ajnr.A2668. Epub 2011 Sep 15.
PubMed 21920854Ross DA, Sandler HM, Balter JM, Hayman JA, Archer PG, Auer DL. Imaging changes after stereotactic radiosurgery of primary and secondary malignant brain tumors. J Neurooncol. 2002 Jan;56(2):175-81. doi: 10.1023/a:1014571900854.
PubMed 11995819Walker AJ, Ruzevick J, Malayeri AA, Rigamonti D, Lim M, Redmond KJ, Kleinberg L. Postradiation imaging changes in the CNS: how can we differentiate between treatment effect and disease progression? Future Oncol. 2014 May;10(7):1277-97. doi: 10.2217/fon.13.271.
PubMed 24947265
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging After Stereotactic Radiosurgery for Brain Metastases or Primary Tumor Can Hybrid PET-MRI Differentiate Between Radiation Effects and Disease ?
- ClinicalTrials.gov ID
- NCT03068520
- Acronym / sponsor ID
- 022-16-ASMC
- Conditions
- Brain Tumor
- Keywords
- PET, MRI, BRAIN METASTASIS, BRAIN PRIMARY TUMOR, RESPONSE TO TREATMENT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Collaborators
- Rabin Medical Center
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Distinguish between progressive tumor and treatment related effects
- To identify pseudo-response to antiangiogenic therapy from tumor progression
- To optimize the study protocol of PET-MRI for future routine clinical application.
The study will include three cohorts of patients with brain tumors:
- 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
- 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
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRIMARY BRAIN TUMOR (PBT) | Other | Diagnostic Test: PET MRpatients with PBT (Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma), before treatment with radiation and chemotherapy.will be followed with PET MRI |
| METASTATIC BT TREATED BY SRS | Other | Diagnostic Test: PET MRpatients 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 |
| METASTATIC BT NOT TREATED BY SRS | Other | Diagnostic Test: PET MRpatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- glial tumor with no histological diagnosis
- non breast of lung metastasis
- non compliance
- unable to lay still during the scanning
- mri non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET MRPET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals | Diagnostic test | METASTATIC BT NOT TREATED BY SRS, METASTATIC BT TREATED BY SRS, PRIMARY BRAIN TUMOR (PBT) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Background: PubMed 21435569Horky LL, Treves ST. PET and SPECT in brain tumors and epilepsy. Neurosurg Clin N Am. 2011 Apr;22(2):169-84, viii. doi: 10.1016/j.nec.2010.12.003.
- Background: PubMed 16741298Chen W, Silverman DH, Delaloye S, Czernin J, Kamdar N, Pope W, Satyamurthy N, Schiepers C, Cloughesy T. 18F-FDOPA PET imaging of brain tumors: comparison study with 18F-FDG PET and evaluation of diagnostic accuracy. J Nucl Med. 2006 Jun;47(6):904-11.
- Background: PubMed 25140562Momose T, Nariai T, Kawabe T, Inaji M, Tanaka Y, Watanabe S, Maehara T, Oda K, Ishii K, Ishiwata K, Yamamoto M. Clinical benefit of 11C methionine PET imaging as a planning modality for radiosurgery of previously irradiated recurrent brain metastases. Clin Nucl Med. 2014 Nov;39(11):939-43. doi: 10.1097/RLU.0000000000000561.
- Background: PubMed 17909255Nanni C, Fanti S, Rubello D. 18F-DOPA PET and PET/CT. J Nucl Med. 2007 Oct;48(10):1577-9. doi: 10.2967/jnumed.107.041947. No abstract available.
- Background: PubMed 23325863Verma N, Cowperthwaite MC, Burnett MG, Markey MK. Differentiating tumor recurrence from treatment necrosis: a review of neuro-oncologic imaging strategies. Neuro Oncol. 2013 May;15(5):515-34. doi: 10.1093/neuonc/nos307. Epub 2013 Jan 16.
- Background: PubMed 25830717Tudisca C, Nasoodi A, Fraioli F. PET-MRI: clinical application of the new hybrid technology. Nucl Med Commun. 2015 Jul;36(7):666-78. doi: 10.1097/MNM.0000000000000312.
- Background: PubMed 10487566Kondziolka D, Patel A, Lunsford LD, Kassam A, Flickinger JC. Stereotactic radiosurgery plus whole brain radiotherapy versus radiotherapy alone for patients with multiple brain metastases. Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):427-34. doi: 10.1016/s0360-3016(99)00198-4.
- Background: PubMed 16757720Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
- Background: PubMed 15158627Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8.
- Background: PubMed 19801201Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.
- Background: PubMed 21041710Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
- Background: PubMed 26092877Sahgal A. Point/Counterpoint: Stereotactic radiosurgery without whole-brain radiation for patients with a limited number of brain metastases: the current standard of care? Neuro Oncol. 2015 Jul;17(7):916-8. doi: 10.1093/neuonc/nov087. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Guindy, MD principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET MR in people with Brain Tumor, run by Assuta Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Guindy, MD (972-50-8800102, micahlgu@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068520, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.