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

Malignant Brain Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01266096
• Other study ID #: 10-155
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Tumors
• Melanoma
• Newly Diagnosed or Recurrent Metastatic Melanoma Patients

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†	in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.	2 years
Secondary	Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots.	studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects	1 year
Secondary	Assay particle tracer tissue distributions in tumor tissue specimens		2 years

External Links

•   Memorial Sloan-Kettering Cancer Center