Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Patients with uveal melanoma for which brachytherapy is recommended will be considered and evaluated for enrollment into this study in order to describe the association between radiation treatment and changes in vision and blood flow within these treated eyes. Changes in vision and blood flow will be monitored at yearly intervals over a 5-year period. Up to 60 subjects will be recruited for this group.

Patients with uveal melanoma who have previously undergone I-125 plaque brachytherapy will be considered for enrollment into this study to evaluate blood flow in eyes with more advanced radiation-induced changes. This group will only undergo a one-time study session. Up to 40 subjects will be recruited for this group.

Alison Skalet, MD, PhD

The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.

Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.

In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.

Vascular Response to Brachytherapy Using Functional OCT

Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography

The purpose of this study is to learn how blood flows to tumors in important structures of the eye in patients treated with I-125 plaque brachytherapy for uveal melanoma. This will be assessed using Doppler OCT and OCT angiography technologies.

Describe changes over time in tumor vascularity and vascular caliber as measured by OCT angiography in eyes that have already undergone I-125 plaque therapy and demonstrate signs of radiation-induced changes.

OHSU Knight Cancer Institute

Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology

Symptoms and General Pathology

Eye Diseases

Neoplasm Metastasis

Uveal Neoplasms

Iris Neoplasms

Choroid Neoplasms

Eye Neoplasms

Uveal Diseases

Choroid Diseases

Iris Diseases

Ocular Melanoma

Fine needle aspiration biopsy

J. William Harbour, MD

Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma) develop metastasis. We have found that certain molecular features of the eye tumor can be detected by gene expression profiling and accurately predict which patients will develop metastasis. This molecular test could eventually allow high risk patients to receive preventative therapy to delay or prevent the development of metastasis. The goal of this study is to prospectively validate the predictive accuracy of the gene expression-based molecular test and compare it to monosomy 3, the most common but potentially less accurate molecular marker for metastasis in ocular melanoma.

We have discovered a gene expression profile derived from primary uveal melanomas that accurately predicts which patients will develop metastasis. Tumors with a class 1 gene expression signature have a very low risk, and those with a class 2 signature have a high risk of metastasis. The molecular test was initially performed on tissue obtained from enucleated eyes using commercial microarray platforms. We are now able to perform the molecular test on fine needle biopsy specimens, and we have developed a customized test that has greater dynamic range and sensitivity than commercial microarray platforms. The goal of this study is to validate the prognostic accuracy of the customized platform by performing the molecular test on primary uveal melanomas obtained from enucleation, local tumor resection or fine needle biopsy. Each sample will be diagnosed as either class 1, class 2 or indeterminate. Outcomes will be collected and the ability of the molecular diagnosis to predict metastasis will be evaluated at regular intervals.

Validation of a Molecular Prognostic Test for Eye Melanoma

Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma

Washington University School of Medicine

Retinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Ranibizumab

Angiogenesis Inhibitors

Growth Inhibitors

Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment

intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.

ranibizumab

Paul T Finger, MD

This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria.

The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.

Following plaque brachytherapy as treatment for choroidal melanoma, patients may develop radiation retinopathy. Radiation retinopathy is a progressive condition that leads to blindness in over 50% of cases within 5 years of treatment.

Vascular endothelial growth factor (VEGF) protein is believed to play a critical role in angiogenesis and radiation retinopathy. It is one of the key contributors to physiological or pathological conditions that can stimulate both the formation of new blood vessels and normal vessel incompetence. Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis.

This is an open label, non-randomized active treatment, Phase I trial to assess the safety and tolerability of intravitreal ranibizumab and its ability to reduce radiation retinopathy and potentially limit vision loss associated with this disease.

Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

Genentech, Inc.

The New York Eye Cancer Center

Director

15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study

Alilson Skalet, MD, PhD

The purpose of this study is to see if mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection.

Uveal melanomas are melanocytic tumors that arise in the pigmented tissues of the eye: the iris, ciliary body, and choroid. Iris melanomas rarely metastasize (spread to other tissues or organs). In contrast, uveal melanomas arising in the ciliary body and choroid are highly malignant (cancerous and invasive to other tissues or organs). Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Therefore patients diagnosed with uveal melanoma must cope with not only a life-threatening illness, but also the frightening prospect of significant vision loss. Choroidal melanomas located in the posterior pole, an anatomical area of the eye which includes the optic nerve and macula (central retina), are of particular concern with regards to visual outcome, as radiation treatment to these areas for even the smallest of tumors is often associated with severe vision loss. The accurate diagnosis and treatment of small choroidal melanomas is critical to patient survival. When tumors with metastatic potential are recognized and treated at an early stage, survival prognosis improves dramatically.

The purpose of this study is to learn if malignant (life-threatening) choroidal tumors versus benign (non-life-threatening) tumors will show distinct blood vessel patterns using functional optical coherence tomography (OCT) angiography. Angiography is the mapping of blood vessels. The investigators believe that OCT angiography can provide data which may help in identifying life-threatening tumors at the earliest stages and improve overall survival for patients with this type of melanoma.

Blood Vessel Patterns in Small Choroidal Tumors

Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography

To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of potentially aggressive choroidal tumors. This will be assessed using functional OCT angiography technology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vascular Response to Brachytherapy Using Functional OCT	NCT01955941	Uveal Melanoma		18 Years -	OHSU Knight Cancer Institute
Validation of a Molecular Prognostic Test for Eye Melanoma	NCT00406120	Uveal Neoplasms Choroid Neoplas... Iris Neoplasms	Fine needle asp...	-	Washington University School of Medicine
Validation of a Molecular Prognostic Test for Eye Melanoma	NCT00406120	Uveal Neoplasms Choroid Neoplas... Iris Neoplasms	Fine needle asp...	-	Washington University School of Medicine
Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma	NCT00750399	Radiation Retin... Choroidal Melan...	Ranibizumab ranibizumab	21 Years -	The New York Eye Cancer Center
Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma	NCT00750399	Radiation Retin... Choroidal Melan...	Ranibizumab ranibizumab	21 Years -	The New York Eye Cancer Center
Blood Vessel Patterns in Small Choroidal Tumors	NCT01955915	Small Posterior...		18 Years -	OHSU Knight Cancer Institute

Spots Global Cancer Trial Database for choroid

Every month we try and update this database with for choroid 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 choroid

Every month we try and update this database with for choroid 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 choroid 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.