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Dual-[Hypoxia+Proliferation] PET as a Predictive Biomarker in Recurrent Glioblastoma

Award Number: R01CA308323
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Dual-[Hypoxia+Proliferation] PET as a Predictive Biomarker in Recurrent Glioblastoma - Project Summary/Abstract Glioblastoma Multiforme (GBM) is the most common and most aggressive malignant primary brain tumor, with a median overall survival (OS) of one year despite maximum treatment, including surgery and chemo- radiotherapy (CRT). The predominant radiographic failure post-RT in GBM is primarily within 2 to 3 cm of the tumor bed. This is thought to be in part due to a hypoxic microenvironment yielding radioresistance and promoting angiogenesis, tumor regrowth, and invasion of tumor cells with proliferative phenotype into adjacent normal brain parenchyma, in turn leading to incomplete tumor resection and subsequent local recurrence. Hypoxia and proliferation in GBM are thus intertwined and synergistically contribute to poor OS. Multi-parametric imaging of tumor hypoxia and proliferation can provide detailed information about its microenvironment and yield improved treatment efficacy especially with image-guided tumor resection and CRT. Yet, PET is limited to imaging one tracer at a time, which jeopardizes the clinical feasibility of multi- parametric imaging. Here, we propose to use dual-kinetic modeling of dual-[FMISO+FLT] PET to simultaneously image tumor hypoxia and proliferation. To the best of our knowledge, this is the first time dual- tracer PET will be used clinically. In AIM1, a cohort of GBM patients will undergo pre-operative 30min static dual-[FMISO+FLT] PET at 180min post-radiotracer injection. Patients will undergo maximal safe tumor resection as per standard of care, i.e. PET information will not be used. Dual-[FMISO+FLT] PET avidity will be (a) used for intraoperative neuro-navigation and targeted sampling prior to tumor excision and will be correlated with molecular pathology markers of hypoxia and proliferation; and (b) correlated with the occurrence and site of subsequent recurrence. The overall goal of this aim is to improve surgical resection efficacy and local control in GBM patients using dual-[FMISO+FLT] PET-guided tumor resection in future clinical trials. Our preliminary data showed robust association between the occurrence and site of subsequent local recurrence in GBM, and the presence/absence of residual dual-[FMISO+FLT] avidity outside the resected tumor bed. In AIM2, the prognostic value of dynamic dual-[FMISO+FLT] PET will be assessed in a cohort of GBM patients post maximal safe resection. The FMISO and FLT KRCs will be deduced via dual-compartment kinetic modeling. FMISO and FLT kinetic parameters, and their combination, will be correlated with the location and incidence of local recurrence, time-to-progression, and PFS and OS at 9 and 12 months. In a second pilot study we performed, post-operative pre-RT FMISO PET allowed detecting residual radioresistant disease in 78% of patients in High- Grade Glioma, and differentiating between progressive and pseudo-progressive disease. This study is a stepping-stone for subsequent clinical trials applying dual-[FMISO+FLT], and other potential PET tracer combinations, in biologically-guided surgical resection and CRT, and response-adapted therapy, for GBM and other diseases. The dual-tracer software will be made available to end-users.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $655,014 )
2026	2026	WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY	575 LEXINGTON AVE FL 9	NEW YORK	NY	10022	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	9/10/2026	NEW	$655,014
														Subtotal = $655,014

Grand Total All Awards = $655,014

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Dual-[Hypoxia+Proliferation] PET as a Predictive Biomarker in Recurrent Glioblastoma

Award Number: R01CA308323

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/10/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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