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Ethanol

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Pre-treatment baseline and post treatment follow-up 18F ML-10 PET/CT sessions.

\[18F\]-ML-10 was administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The radiation dose of \[18F\]-ML-10 administered at each session was 300-500 MBq (8.1-13.5 mCi).

([18F]-ML-10)

Yael Cohen

The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as a non-invasive imaging tool for the early detection of apoptosis in brain metastases in response to radiation therapy, in patients subjected to stereotactic radiosurgery (SRS). Such early detection may improve clinical management of patients with brain metastases, as it may help early identification of non-responders, and subsequently potentially lead to optimization of radiation techniques such as the need for whole brain radiation therapy (WBRT), addition of brain penetrating chemotherapy or an early decision on referral of the patient with non-responsive lesions to surgery or to systemic chemotherapy. The experimental design of the present study aims to evaluate the potential of non-invasive PET examination with \[18F\]-ML-10, to provide the clinician with an assessment of response early in the course of treatment, via non-invasive molecular imaging of radiation-induced apoptosis. This information on tumor responsiveness is currently available only several weeks to months after completion of radiotherapy.

Early assessment of the efficacy of anti-cancer therapy is highly desirable and an unmet need in clinical oncology. Currently, treatment efficacy is mostly measured by following tumor size by anatomical imaging (CT scan or MRI). However, changes in tumor size may be observed only after several weeks to several months after completion of treatment. Meanwhile, in cases where there is no response, the patient is unnecessarily exposed to treatment's side effects, and precious time may be lost before the initiation of an alternative, potentially more beneficial line of therapy. Therefore, there is an urgent and serious need for better tools for monitoring of tumor response to anti-cancer treatments.

To address this need, \[18F\]-ML-10, a novel small molecular-weight probe (MW 205) was developed for clinical detection of apoptosis in vivo by positron emission tomography (PET). \[18F\]-ML-10 is a member of the ApoSense family of compounds, a novel class of molecular probes for molecular imaging of cell death. The first clinical indication for which \[18F\]-ML-10 is being developed is imaging of apoptosis in clinical oncology to monitor tumor response to radiation therapy.

Previous preclinical and clinical studies have substantiated the safety of \[18F\]-ML-10, its very high stability in vivo, its favorable biodistribution profile, and its efficacy in clinical detection of cell death. In preclinical studies, the selective retention of \[18F\]-ML-10 in the focus of the neurovascular cell death in cerebral ischemia was demonstrated in respective animal models. \[18F\]-ML-10 has been examined in two clinical trials in Uppsala Imanet, Sweden, and has been found safe in administration to healthy subjects and to elderly subjects with acute ischemic cerebral stroke. In these clinical trials, \[18F\]-ML-10 was also found efficacious in the clinical imaging of apoptosis, being either physiological apoptosis as observed in the testes in young healthy males, and pathological cell death, as observed in the brains of patients with acute ischemic cerebral stroke.

18F ML-10 for Early Detection of Response of Brain Metastases to SRS

An Open-label, Multi-center Study to Evaluate [18F]-ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Stereotactic Radio Surgery (SRS)

Aposense Ltd.

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Sampling of 2 samples on the extracorporeal photochemotherapy circuit, before and after sensitization with 8-MOP and UVA irradiation (without additional puncture)

Samples collection

Charline VAUCHY, PhD

Charline Vauchy, PhD

Thomas CREPIN, MD

The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.

Extracorporeal photochemotherapy (ECP) is a cell therapy used for its immunomodulation and tolerance induction capabilities. Its main indications are the control of graft-versus-host (GVH) disease in hematopoietic cell allografts, treatment and control of rejection in solid organ transplantation and the treatment of cutaneous T-cell lymphoma. Data on the mechanisms of action of ECP remains very patchy. This lack of data limits the discussion on therapeutic regimens by disease.

ECP consists of repeated apheresis sessions to collect leukocytes from the patient. The cells are then photosensitized, irradiated with UVA and reinjected into the patient in a closed circuit. In the context of GVH, induced cell death would stimulate the expansion of regulatory cells (Treg), restore a Th1/Th2 balance and decrease Th17 polarization. The ECP also allows the expansion of Treg in solid organ transplantation. Conversely, ECP would restore or activate an antitumor immune response in cutaneous T lymphoma.

The type of cells collected and treated would play a major role in the effects obtained. However, these hypotheses must be consolidated, in particular by detailing the initial role of cell death. Several questions remain, on the chronology of cell death in the different treated subpopulations, on the uptake by phagocytes, but especially on the type of cell death induced according to the cell type (necroptosis, apoptosis, pyroptosis, autophagy). The data generated will allow for validation or detail of the mechanisms of resolution of the inflammation and/or the anti-tumour effect observed.

MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy

MLKL (mixed lineage kinase domain-like pseudokinase) phosphorylation in Western blot

Centre Hospitalier Universitaire de Besancon

Anti-Allergic Agents

Anti-Inflammatory Agents

Radiopharmaceuticals

Fluorometholone

\[18F\]-ML-10 will be radiolabeled at the PET Radioactive Drug Production (RDP) facility at or in close proximity to each clinical site, and will be administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The dose concentration selected for \[18F\]-ML-10 will be 7 MBq/Kg or 0.19 mCi/Kg. The radioactivity dosage of \[18F\]-ML-10 administered at each PET/CT session will be at least 300 MBq (8.1 mCi) and not more than 500 MBq (13.5 mCi).

2-(5-fluoro-pentyl)-2-methyl-malonic-acid ([18F]-ML-10)

SRS will be administered according to the standard of care using a radiation dose of 14-24 Gy to each lesion.

Stereotactic Radio-Surgery (SRS) therapy

Each patient will undergo 2 PET/CT sessions, each following intravenous administration of \[18F\]-ML-10, to assess tracer uptake by the brain metastases treated by SRS. The PET/CT scan will be directed to the brain and will include one bed position. The PET/CT sessions will be performed at baseline, i.e., before the radiation treatment, and on the day after, within 24h after SRS treatment.

Positron Emission Tomography

Juho Whang

Eric Wong, MD

Elysia Larson

Stephanie E Weiss, MD

Gina Giannantoni-ibelli

Kathryn Beal, MD

Rhonda Berlin

Heron Dwight, MD

The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as an imaging tool for the early detection of response of brain metastases to radiation therapy. Such early detection may help early identification of responsive and non-responsive lesions. The experimental design of the present study aims to evaluate the potential of PET imaging with \[18F\]-ML-10 to address the currently unmet clinical need for very early (within one day)assessment of response to therapy. Currently, response assessment is available only after several weeks or months after completion of therapy, when tumor shrinkage can be detected by anatomical imaging (by MRI). Early detection of tumor response to treatment is now widely-recognized as a highly-desirable goal in oncology, and is respectively the target of intense research worldwide. In the future, the option to know early upon treatment administration, that the treated tumor is a non-responsive, may improve clinical management of patients with brain metastases of solid tumors.

Early assessment of the efficacy of anti-cancer therapy is highly desirable and an unmet need in clinical oncology. Currently, treatment efficacy is mostly measured by following tumor size by anatomical imaging (CT scan or MRI). However, changes in tumor size may be observed only after several weeks to several months after completion of treatment. Meanwhile, in cases where there is no response, the patient is unnecessarily exposed to treatment's side effects, and precious time may be lost before the initiation of an alternative, potentially more beneficial line of therapy. Therefore, there is an urgent and serious need for better tools for monitoring of tumor response to anti-cancer treatments.

To address this need, \[18F\]-ML-10, a novel small molecular-weight probe (MW 205) was developed for clinical detection of apoptosis in vivo by positron emission tomography (PET). \[18F\]-ML-10 is a member of the Aposense family of compounds, a novel class of molecular probes for molecular imaging of cell death. The proposed indication for which \[18F\]-ML-10 is being developed is for early assessment of response of solid tumors to radiation and chemoradiation therapy.

Previous preclinical and clinical studies have substantiated the safety of \[18F\]-ML-10, its very high stability in vivo, its favorable biodistribution profile, and its efficacy in clinical detection of cell death. In preclinical studies, the selective retention of \[18F\]-ML-10 in the focus of the neurovascular cell death in cerebral ischemia was demonstrated in respective animal models. \[18F\]-ML-10 has been examined in two clinical trials in Uppsala Imanet, Sweden, and has been found safe in administration to healthy subjects and to elderly subjects with acute ischemic cerebral stroke. In these clinical trials, \[18F\]-ML-10 was also found efficacious in the clinical imaging of apoptosis, being either physiological apoptosis as observed in the testes in young healthy males, and pathological cell death, as observed in the brains of patients with acute ischemic cerebral stroke.

Additional Phase 2 study demonstrated the suitability and safety of 18F-ML-10, designed to serve as a PET radiotracer for early detection of cellular apoptosis of brain metastases in response to WBRT. The relationship between the early change in 18F-ML-10 uptake by the tumor, observed during or upon completion of treatment, and subsequent tumor shrinkage as observed by MRI eight weeks after the completion of WBRT, was demonstrated.18F-ML-10 demonstrated a good safety profile with no drug-related AEs or any effect on safety parameters.

Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.

Evaluation of Efficacy and Safety of 18FML10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Non-Hematological Solid Tumors to Radiation Therapy

Miri Ben-Ami, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F ML-10 for Early Detection of Response of Brain Metastases to SRS	NCT00696943	Metastasis to B...	([18F]-ML-10)	18 Years -	Aposense Ltd.
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy	NCT05333367	Cutaneous T-Cel... Graft Vs Host D... Graft Rejection	Samples collect...	18 Years - 85 Years	Centre Hospitalier Universitaire de Besancon
Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.	NCT00805636	Brain Metastase... Solid Tumors	2-(5-fluoro-pen... Stereotactic Ra... Positron Emissi...	18 Years -	Aposense Ltd.
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy	NCT05333367	Cutaneous T-Cel... Graft Vs Host D... Graft Rejection	Samples collect...	18 Years - 85 Years	Centre Hospitalier Universitaire de Besancon
MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy	NCT05333367	Cutaneous T-Cel... Graft Vs Host D... Graft Rejection	Samples collect...	18 Years - 85 Years	Centre Hospitalier Universitaire de Besancon
Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.	NCT00805636	Brain Metastase... Solid Tumors	2-(5-fluoro-pen... Stereotactic Ra... Positron Emissi...	18 Years -	Aposense Ltd.
18F ML-10 for Early Detection of Response of Brain Metastases to SRS	NCT00696943	Metastasis to B...	([18F]-ML-10)	18 Years -	Aposense Ltd.

Spots Global Cancer Trial Database for cell death

Every month we try and update this database with for cell death cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cell death

Every month we try and update this database with for cell death cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cell death cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.