Hypoxia Imaging Techniques for Liver Cancer
Recruiting in Palo Alto (17 mi)
Overseen ByNima Kokabi, MD, FRCPC
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Emory University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial evaluates using tiny radioactive beads to treat liver cancer that has spread to a few sites. The treatment involves placing these beads into the blood vessels feeding the tumor, blocking its blood supply and delivering targeted radiation. This approach aims to kill cancer cells while protecting healthy tissue.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for liver cancer?
Research shows that using 18F-Fluoromisonidazole PET/CT imaging can help identify areas of low oxygen (hypoxia) in tumors, which can improve the targeting of radiation therapy in lung and head and neck cancers. This suggests that similar imaging techniques might help optimize radiation treatment for liver cancer by better targeting the tumor.
12345Is Yttrium-90 Selective Internal Radiation Therapy (SIRT) safe for humans?
Yttrium-90 Selective Internal Radiation Therapy (SIRT) has been used safely in clinical settings for over two decades, with its safety and effectiveness confirmed for treating liver cancers. It is approved by international guidelines, and while it involves radiation, it is designed to target liver tumors specifically, minimizing exposure to healthy liver tissue.
678910How does hypoxia imaging differ from other treatments for liver cancer?
Hypoxia imaging for liver cancer is unique because it uses advanced imaging techniques like PET/CT to detect low oxygen areas in tumors, which can help tailor treatments more effectively. Unlike traditional treatments, this approach focuses on identifying and targeting hypoxic (low oxygen) regions that are often resistant to standard therapies.
511121314Eligibility Criteria
This trial is for adults with liver cancer that has spread but not widely (oligometastatic). They should have at least one tumor larger than 3 cm, be in relatively good health (ECOG <=2), and have a life expectancy over 12 weeks. Women must test negative for pregnancy and all participants agree to use birth control. People with widespread liver cancer, poor liver function, or other serious health issues are excluded.Inclusion Criteria
My cancer has spread to a few other parts of my body.
I can take care of myself but might not be able to do heavy physical work.
My liver cancer is at an early to intermediate stage.
I have a tumor that is at least 3 cm big.
I am 18 years old or older.
My liver cancer affects one or both lobes of my liver.
Exclusion Criteria
I have had treatments specifically aimed at liver tumors.
I have another type of cancer besides the one in my liver.
My liver tumor is spreading into nearby tissues.
My liver cancer is in the most advanced stage.
My liver is expected to receive more than 30 Gy of radiation in one session.
Participant Groups
The study tests if measuring low oxygen areas can predict outcomes of Y90 selective internal radiation therapy in oligometastatic liver cancer patients. It involves placing radioactive beads near the tumor to block blood flow and deliver high doses of radiation directly while sparing healthy tissue.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)Experimental Treatment4 Interventions
Patients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Emory University Hospital/Winship Cancer InstituteAtlanta, GA
Loading ...
Who is running the clinical trial?
Emory UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Multimodal hypoxia imaging and intensity modulated radiation therapy for unresectable non-small-cell lung cancer: the HIL trial. [2021]Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different therapy protocols is variable, with hypoxia known to be a major factor that negatively influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might allow optimized dose applications to the target volume, leading to improvement of therapy outcome. (18)F-fluoromisonidazole dynamic positron emission tomography and computed tomography ((18) F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive options for imaging tumor hypoxia.
The influence of changes in tumor hypoxia on dose-painting treatment plans based on 18F-FMISO positron emission tomography. [2021]To evaluate how changes in tumor hypoxia, according to serial fluorine-18-labeled fluoro-misonidazole (18F-FMISO) positron emission tomography (PET) imaging, affect the efficacy of intensity-modulated radiotherapy (IMRT) dose painting.
[Value of 18F-FETNIM PET-CT for detection of tumor hypoxia in non-small-cell lung cancer]. [2019]To assess the feasibility of [(18)F]fluoroerythronitroimidazole ((18)F-FETNIM) with integrated positron emission tomography and computed tomography (PET-CT) imaging in detection of hypoxia in non-small-cell lung cancer (NSCLC) patients.
Planning study for available dose of hypoxic tumor volume using fluorine-18-labeled fluoromisonidazole positron emission tomography for treatment of the head and neck cancer. [2016]To investigate the feasibility of fluorine-18-labeled fluoromisonidazole positron emission tomography/computed tomography ((18)F-FMISO PET/CT)-guided intensity-modulated radiotherapy (IMRT) in dose escalation to attack the hypoxic volume of a tumor mass without increasing the normal tissue dose in head and neck cancer patients.
A Comparative Study of Noninvasive Hypoxia Imaging with 18F-Fluoroerythronitroimidazole and 18F-Fluoromisonidazole PET/CT in Patients with Lung Cancer. [2018]This is a clinical study to compare noninvasive hypoxia imaging using 18F-fluoroerythronitroimidazole (18F-FETNIM) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography/computed tomography (PET/CT) in patients with inoperable stages III-IV lung cancer.
[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]Liver malignant tumors are one of the most common causes of cancer-related deaths in China. Selective internal yttrium-90 radioembolization therapy ((90)Y-SIRT) is a kind of promising local minimally invasive method, and its effectiveness and safety has been confirmed in clinical application over the past two decades. Moreover, it has been approved by the U.S. National Comprehensive Cancer Network and other international guidelines for the topical treatment of patients with liver malignancies. Taking into account the complexity of the (90)Y-SIRT and the need for multidisciplinary collaboration to improve the safety and success rate of treatment, the Nuclear Medicine Expert Committee of the Chinese society of Clinical Oncology, along with Beijing Nuclear Medicine Quality Control and Improvement Center invited experts from surgical oncology, interventional medicine, nuclear medicine, and other related fields to discuss and form a consensus on the clinical diagnosis, treatment and management, which mainly included definition, indications and contraindications, treatment procedures, postoperative follow-up, adverse reactions and complications, radiation safety management, etc. Herein, we provide the reference guidance to establish (90)Y-SIRT standardized management and treatment system various units for relevant practitioners.
Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. [2019]Selective intraarterial radionuclide therapy (SIRT) with yttrium-90 (Y-90) resin microspheres presently has successful results in primary or metastatic inoperable liver tumors. This procedure, which is also known as radioembolisation, delivers high doses of radiation selectively to hepatic tumors while minimum healthy liver exposure. The aim of this study was to present our clinical experience of radiomicrosphere therapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Outcomes and Predictors of Toxicity after Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres for Unresectable Hepatocellular Carcinoma. [2020]We sought to report outcomes and toxicity in patients with hepatocellular carcinoma (HCC) who received resin yttrium-90 selective internal radiation therapy ((90)Y-SIRT) and to identify factors associated with declining liver function.
90Yttrium PET/MR-based dosimetry after liver radioembolization (SIRT). [2018]Biodistribution and dosimetric aspects are important issues in the preparation realization of radionuclide therapies and thus play an emerging role in radioembolization of liver malignancies. Biodistribution assessment of liver selective internal radiotherapy (SIRT) has been shown feasible using PET/CT PET/magnetic resonance (MR). Whereas prospective dosimetry using 99mTc macroaggregated albumin SPECT/CT is discussed controversially, retrospective 90Y PET/CT has been shown feasible for dosimetry of SIRT in recent studies. Considering the advantages of PET/MR with regard to lesion detection radiation dose reduction compared to PET/CT, especially when repeated scanning is intended, we investigated the use of PET/MR for dosimetry of liver SIRT.
Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. [2020]Selective internal radiotherapy (SIRT) with yttrium-90 (Y-90) is an intra-arterial therapy for hepatic malignancy in patients who are unsuitable for surgical resection. This treatment is considered palliative, although some patients can demonstrate a response that is adequate to facilitate surgical resection with curative intent.
Advances in PET and MRI imaging of tumor hypoxia. [2023]Tumor hypoxia is a complex and evolving phenomenon both in time and space. Molecular imaging allows to approach these variations, but the tracers used have their own limitations. PET imaging has the disadvantage of low resolution and must take into account molecular biodistribution, but has the advantage of high targeting accuracy. The relationship between the signal in MRI imaging and oxygen is complex but hopefully it would lead to the detection of truly oxygen-depleted tissue. Different ways of imaging hypoxia are discussed in this review, with nuclear medicine tracers such as [18F]-FMISO, [18F]-FAZA, or [64Cu]-ATSM but also with MRI techniques such as perfusion imaging, diffusion MRI or oxygen-enhanced MRI. Hypoxia is a pejorative factor regarding aggressiveness, tumor dissemination and resistance to treatments. Therefore, having accurate tools is particularly important.
Hypoxia PET/CT imaging: implications for radiation oncology. [2016]Hypoxia, a condition of reduced partial pressure of oxygen in tissue, is an important determinant of poor tumor response to radiation treatment. Many invasive and non-invasive methods and approaches have been investigated to detect tumor hypoxia for response prediction and to facilitate modulation of radiation treatment. In this review we discuss the biological consequences of tumor hypoxia, methods of measuring regional tumor hypoxia with positron emission tomography (PET) tracers and applications for radiation oncology.
Imaging tumoral hypoxia: oxygen concentrations and beyond. [2016]The role of hypoxia as a key determinant of outcome for human cancers has encouraged efforts to noninvasively detect and localize regions of poor oxygenation in tumors. In this review, we will summarize existing and developing techniques for imaging tumoral hypoxia. A brief review of the biology of tumor oxygenation and its effect on tumor cells will be provided initially. We will then describe existing methods for measurement of tissue oxygenation status. An overview of emerging molecular imaging techniques based on radiolabeled hypoxic markers such as misonidazole or hypoxia-related genes and proteins will then be given, and the usefulness of these approaches toward targeting hypoxia directly will be assessed. Finally, we will evaluate the clinical potential of oxygen- and molecular-specific techniques for imaging hypoxia, and discuss how these methods will individually and collectively advance oncology.
Longitudinal PET imaging of tumor hypoxia during the course of radiotherapy. [2019]Hypoxia results from an imbalance between oxygen supply and consumption. It is a common phenomenon in solid malignant tumors such as head and neck cancer. As hypoxic cells are more resistant to therapy, tumor hypoxia is an indicator for poor prognosis. Several techniques have been developed to measure tissue oxygenation. These are the Eppendorf O2 polarographic needle electrode, immunohistochemical analysis of endogenous (e.g., hypoxia-inducible factor-1α (HIF-1a)) and exogenous markers (e.g., pimonidazole) as well as imaging methods such as functional magnetic resonance imaging (e.g., blood oxygen level dependent (BOLD) imaging, T1-weighted imaging) and hypoxia positron emission tomography (PET). Among the imaging modalities, only PET is sufficiently validated to detect hypoxia for clinical use. Hypoxia PET tracers include 18F-fluoromisonidazole (FMISO), the most commonly used hypoxic marker, 18F-flouroazomycin arabinoside (FAZA), 18Ffluoroerythronitroimidazole (FETNIM), 18F-2-nitroimidazolpentafluoropropylacetamide (EF5) and 18F-flortanidazole (HX4). As technical development provides the opportunity to increase the radiation dose to subregions of the tumor, such as hypoxic areas, it has to be ensured that these regions are stable not only from imaging to treatment but also through the course of radiotherapy. The aim of this review is therefore to characterize the behavior of tumor hypoxia during radiotherapy for the whole tumor and for subregions by using hypoxia PET tracers, with focus on head and neck cancer patients.