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18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New Jersey
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Basking Ridge, New Jersey, Verenigde Staten
- Memoral Sloan Kettering Cancer Center
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Middletown, New Jersey, Verenigde Staten, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack, New York, Verenigde Staten, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison, New York, Verenigde Staten, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, Verenigde Staten, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, Verenigde Staten
- Memorial Sloan Kettering at Mercy Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
- Life expectancy of >12 weeks.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Creatinine ≤2.0 times the upper limit of normal.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.
- No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation of WBRT. Please note: there is no washout period required for trastuzumab, pertuzumab, for patients who have developed new parenchymal brain metastases while on these agents.
Exclusion Criteria:
- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.
- Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
- Inability to comply with protocol and /or not willing or not available for follow-up assessments.
- Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.
- Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
- Claustrophobia
- Known allergic reaction to Gd-DTPA
- Renal insufficiency with recent (<3 month old) creatinine >2.0
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Cohort 1
Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial).
We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
Experimenteel: Cohort 2
Cohort 2 will include patients treated with standard WBRT alone.
Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate
Tijdsspanne: 1 year
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Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Avg SUV Max From Baseline to 1 Year
Tijdsspanne: 1 year
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Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis.
In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies.
For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.
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1 year
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Andrew Seidman, MD, Memorial Sloan Kettering Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-039
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