PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Sili… (NCT01266096) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
United States10 participantsStarted 2011-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 opin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†