Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Etoposide phosphate

Enzyme Inhibitors

Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.

During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation).

After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.

After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3

Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions

Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Radiotherapy

Michael Poulsen

A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.

Merkel Positron Emission Tomography (PET) Protocol

A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin

Trans Tasman Radiation Oncology Group

Glioma

Neoplasms, Neuroepithelial

Frovatriptan

Performed on a 3.0 Tesla Philips Intera MRI Unit (Best, Netherlands). Scout views and T2 transverse images are obtained to locate the tumor in conjunction with any previous diagnostic images.

MRS Imaging

Using an Allegro scanner, the patient will be scanned for approximately 20-30 minutes. All emission scan data is processed by a multi-step procedure.

PET Scanning

Subjects will be scanned with a 3T Philips Intera MRI scanner for approximately 26 minutes for anatomical and DTI imaging. Total DTI acquisition time will be 6:06 minutes with 40 contiguous axial slices for full brain coverage.

Diffusion Tensor Imaging

Albert Murtha, MD, FRCPC

Gliomas are one of the most challenging tumors to treat, because areas of the apparently normal brain contain microscopic deposits of glioma cells; indeed, these occult cells are known to infiltrate several centimeters beyond the clinically apparent lesion visualized on standard computer tomography or magnetic resonance imaging (MR). Since it is not feasible to remove or radiate large volumes of the brain, it is important to target only the visible tumor and the infiltrated regions of the brain. However, due to the limited ability to detect occult glioma cells, clinicians currently add a uniform margin of 2 cm or more beyond the visible abnormality, and irradiate that volume. Evidence, however, suggests that glioma growth is not uniform - growth is favored in certain directions and impeded in others. This means it is important to determine, for each patient, which areas are at high risk of harboring occult cells. We propose to address this task by learning how gliomas grown, by applying Machine Learning algorithms to a database of images (obtained using various advanced imaging technologies: MRI, MRS, DTI, and MET-PET) from previous glioma patients. Advances will directly translate to improvements for patients.

Gliomas are the most common primary brain tumors in adults; most are high-grade and have a high level of mortality. The standard treatment is to kill or remove the cancer cells. Of course, this can only work if the surgeon or radiologist can find these cells. Unfortunately, there are inevitably so-called "occult" cancer cells, which are not found even by today's sophisticated imaging techniques.

This proposal proposes a technology to predict the locations of these occult cells, by learning the growth patterns exhibited by gliomas in previous patients. We will also develop software tools that help both practitioners and researchers find gliomas similar to a current one, and that can autonomously find the tumor region within a brain image, which can save radiologists time, and perhaps help during surgery.

Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology

Eligible patients will be given the opportunity to undergo additional diagnostic imaging. These images will be anonymized and databased. the data will be analyzed using machine learning techniques.

AHS Cancer Control Alberta

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anti-Infective Agents

Deoxyglucose

Antimetabolites

Antiviral Agents

All participants will receive multi-tracer PET scans at up to 3 time points: baseline, at the conclusion of standard of care chemoradiation, and at the time of documented recurrence within two years.

Brain scan with metabolic imaging tracer that aids in assessment, diagnosis, and staging of patients with cancer.

[18F]fluoro-2-deoxy-D-glucose (FDG)

Brain scan with a radiolabeled imaging agent for investigating cellular proliferation of tumors

3'-deoxy-3'-[18F]fluorothymidine (FLT)

Brain scan with imaging agent to determine tumor blood flow

[15O]-H2O

Brain scan with imaging agent to determine growth activity of tumor

[11C]Acetate

John M Hoffman, MD

Daniel Kadrmas, PhD

Randy Jensen, MD,PhD

Howard Colman, MD,PhD

The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide administered for 5 consecutive days every 4 weeks \[Stupp 2005\]. Contrast-enhanced MRI is the current standard for evaluating the success of therapy and monitoring for tumor recurrence. MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy until evidence of recurrence. Despite this careful clinical and radiographic surveillance, and despite decades of research into the histologic and molecular classification of primary brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will result in overall survival times of only months, whereas other histologically-identical gliomas may yield survivals of years to decades \[Carson 2007, Curran 1993, Lamborn 2004\]. Current assessment of tumor response to therapy is also poor. Patients with complete radiographic response after cranial irradiation often progress rapidly post-irradiation. In contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond dramatically to further chemotherapy alone, or the masses may even disappear in the absence of further therapy (so called "tumor pseudoprogression") \[Chamberlain 2007\]. This confounding situation demonstrates a need for better assessment of tumor response.

Positron emission tomography (PET) is a molecular imaging modality that can probe various aspects of tumor function using a variety of radio-labeled imaging agents ("tracers"). Oncologic PET imaging has seen a dramatic rise in clinical utilization over the past decade for cancer detection, staging, and evaluating residual or recurrent disease following therapy. These clinical scans use the tracer \[18F\]fluoro-2-deoxy-D-glucose (FDG), which accumulates in cells in proportion to glucose (GLUT) transporter and hexokinase activity. FDG thus provides a measure of tissue glucose metabolism. Concurrent with this clinical growth, a number of other PET tracers have received significant attention in research for a variety of imaging targets. Of special interest are the tracers 3'-deoxy-3'-\[18F\]fluorothymidine (FLT), 1-\[11C\]-acetate (ACE), and \[15O\]water (H2O). The uptake, retention/washout, and ultimate biodistribution of these tracers are each related to different functional or molecular processes. As such, each can be used to probe a different aspect of tumor function: FLT directly assesses tumor proliferation, ACE provides a measure of tumor growth related to fatty acid and membrane synthesis, and H2O quantifies tumor perfusion.

OBJECTIVES:

This study has two primary objectives: a translational objective in which a new PET imaging technology will be translated from experimental development (with simulations and in animals) to the first use in human subjects; and an exploratory objective in which the complementary value of multiple PET tracers will be investigated. Each of these objective is described below, where the study design has been carefully setup to fulfill both objectives in the same study population.

The translational objective of this study is to implement and evaluate a new imaging technology for rapid, single-scan multi-tracer PET imaging of these tracers. Current PET technology prohibits imaging of more than one tracer in a single scan since the imaging signals from each tracer cannot be distinguished by normal techniques; as such, separate scans with each tracer currently need to be acquired hours or days apart. Our group has developed techniques and algorithms for recovering individual-tracer images from rapidly-acquired multi-tracer PET data using dynamic imaging techniques. These methods have been tested through extensive simulations and verified experimentally in a canine model with spontaneously-occurring tumors. Refinement of the methods with more advanced algorithms is ongoing. The patient imaging studies of this protocol will be implemented in two phases. In Phase A, separate single-tracer imaging of each tracer will be performed. The data from these scans will be co-registered and combined to "emulate" multi-tracer scans, which will then be processed by the multi-tracer signal-separation algorithms. This will permit a direct comparison of imaging biomarkers from multi-tracer vs. single-tracer scans for each tracer. Such comparison techniques have been established by the investigators and have been accepted by peer review for testing multi-tracer signal-separation algorithms. Once statistically-significant evidence is obtained that multi-tracer scans can accurately provide the same imaging biomarkers as separate single-tracer scans, the imaging will transition to Phase B-in which actual multi-tracer scans will be performed.

The objectives of this exploratory study is to preliminarily evaluate the complementary value of FDG, FLT, ACE, and H2O PET in patients with primary glial neoplasms. Multi-tracer PET profiles with these four tracers will be obtained in 20 patients with primary glial neoplasms at up to three timepoints: (1) at "baseline" prior to surgery or immediately after surgery providing a complete surgical resection was not possible and confirmed by a post-operative contrast MRI scan where residual tumor greater than 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (\~6-8 weeks) chemoradiotherapy; and (3) at the time of MRI-documented recurrence within 2 years. In addition, patients with a known primary brain tumor who have previously undergone treatment and have recurred based on standard clinical and imaging criteria will be eligible for the study. A number of quantitative and pseudo-quantitative imaging biomarkers for each tracer will be computed at each imaging timepoint, and the change in each biomarker between timepoints will also be computed. These data will be compared with clinical endpoints (survival, time to progression), and with tumor biologic information (histology, WHO grade, vascularity, Ki-67, vascular endothelial growth factor (VEGF), epidermal growth factor receptor (EGFR), p53) in cases when tumor tissue becomes available from standard care. These data will provide pilot information into the potential value of concurrent multiple PET biomarkers for predicting tumor behavior prior to the start of therapy, for improved prognostication, for more efficient and effective tumor surveillance, and/or for more appropriate assignment of patients to conventional, aggressive, or investigational therapies early in their clinical courses.

The driving hypothesis for the overall line of research is that multiple PET imaging biomarkers obtained in conjunction can provide improved image-guided personalized care of patients with primary glial neoplasms. The term "personalized care" is used here to broadly include the prediction of tumor behavior prior to the start of therapy, tumor surveillance, prognostication, and individualized assignment of patients to conventional, aggressive, or investigational therapies early in their clinical courses. This pilot project will obtain initial data on the value of these PET biomarkers for such image-guided personalized care.

Specific hypotheses to be tested include:

* HYPOTHESIS I a: Rapid, single-scan multi-tracer PET imaging can recover PET imaging biomarker information of each tracer that are not significantly different from those obtained from conventional, single-tracer scans of each tracer.
* HYPOTHESIS II b: Multi-tracer PET biomarkers, obtained in conjunction, are better able to predict tumor aggressiveness than individual-tracer biomarkers or conventional radiographic imaging.
* HYPOTHESIS III b: Multi-tracer PET biomarkers, obtained in conjunction, are better able to detect functional changes in tumor state that occur in response to therapy than individual-tracer biomarkers or conventional radiographic imaging.
* HYPOTHESIS IV b: Characterization of multiple aspects of tumor function (glucose metabolism, proliferation, membrane growth, and perfusion) provides new insight into tumor status that can guide selection of the most appropriate therapy.

a Sufficient statistical power is expected to be obtained under this protocol to validate the extensive simulations and experimental evaluations performed previously and concurrently with these patient imaging studies.

b Pilot data regarding these three hypotheses will be obtained in this work by studying the correlation of PET imaging biomarkers with clinical outcomes and tumor biologic information. Though high statistical power cannot be expected from the limited number of patients in this pilot study, underlying trends in the data will be identified, permitting the formulation of formal hypotheses to be tested in future rigorous trials.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Merkel Positron Emission Tomography (PET) Protocol	NCT01013779	Merkel Cell Car...	Carboplatin Etoposide Radiotherapy	18 Years -	Trans Tasman Radiation Oncology Group
Identification of Clinically Occult Glioma Cells and Characterization of Glioma Behavior Through Machine Learning Analysis of Advanced Imaging Technology	NCT00330109	Glioma	MRS Imaging PET Scanning Diffusion Tenso...	18 Years -	AHS Cancer Control Alberta
Multi-Tracer PET Assessment of Primary Brain Tumors	NCT00813566	Brain Tumors Cancer	[18F]fluoro-2-d... 3'-deoxy-3'-[18... [15O]-H2O [11C]Acetate	18 Years -	University of Utah

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