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Clinical Trial Finder

Search Results

PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study

Study Purpose

Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use special dyes that are injected into a vein and can better localize possible cancer. The investigators have developed a new particle that can carry a radioactive dye to a very specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas of possible disease. This particle has been studied in mice and was safe. The particles will not treat the cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 18 years of age or older.
  • - Histologically confirmed diagnosis of melanoma or malignant brain tumor at MSKCC.
  • - Newly-diagnosed or recurrent (local,regional, metastatic) metastatic melanoma or malignant brain tumor patients with.
  • - Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas or malignant brain tumor.
  • - Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
  • - Newly diagnosed patients with previous excisional biopsy.
  • - Normal baseline cardiac function based upon pre-operative evaluation.
  • - At the discretion of the physician ANC>1000/mcl and platelets>100,000/mcl.
  • - At the discretion of the physician Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
  • - If patients have a history of malignancy other than melanoma or malignant brain tumor they must be disease-free (excluding primary cancer for metastatic patients) for ≥ 5 years at the time of enrollment.
  • - All patients of childbearing and child-creating age must be using an acceptable form of birth control.
  • - Women who are pre-menopausal must have a negative serum pregnancy test.

Exclusion Criteria:

  • - Abnormal thyroid function, such as untreated clinical diagnosis of hypothyroidism, hyperthyroidism, or other thyroid disease.
  • - Known pregnancy or breast-feeding.
  • - Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the tracer.
This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.
  • - History of any malignancy (excluding primary cancer for metastatic patients) other than melanoma or malignant brain tumors for which the disease-free interval is <5 years.
  • - Allergic reaction to iodine-containing contrast material.
  • - Weight greater than the 400-lb weight limit of the PET scanner.
  • - Claustrophobia.
- Inability to lie in the scanner for 30 minutes

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01266096
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hilda Stambuk, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Newly Diagnosed or Recurrent Metastatic Melanoma Patients, Malignant Brain Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: newly diagnosed or recurrent head/neck melanoma

This is a two-year microdosing study that will enroll 5 metastatic melanoma patients and 18 malignant brain tumor patients (surgical (n=13) and non-surgical candidates (n=5)). We have already accrued 5 melanoma patients and expect to accrue brain tumor patients within a 1 year period.

Interventions

Drug: - PET scan with 124I-cRGDY-PEG-dots

Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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