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

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ClinicalTrials.gov Identifier: NCT01266096
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE December 21, 2010
First Posted Date  ICMJE December 24, 2010
Last Update Posted Date October 27, 2020
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots† [ Time Frame: 2 years ]
in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
objective is to perform a microdosing or first-in-man diagnostic PET study to evaluate human biodistribution to organs/tissues/tumor [ Time Frame: 1 year ]
to a limited number of human melanoma patients to characterize biodistribution, pharmacokinetics, and metabolic stability.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots. [ Time Frame: 1 year ]
    studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects
  • Assay particle tracer tissue distributions in tumor tissue specimens [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots. [ Time Frame: 1 year ]
studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Official Title  ICMJE PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Newly Diagnosed or Recurrent Metastatic Melanoma Patients
  • Malignant Brain Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: PET scan with 124I-cRGDY-PEG-dots
Publications * Phillips E, Penate-Medina O, Zanzonico PB, Carvajal RD, Mohan P, Ye Y, Humm J, Gönen M, Kalaigian H, Schöder H, Strauss HW, Larson SM, Wiesner U, Bradbury MS. Clinical translation of an ultrasmall inorganic optical-PET imaging nanoparticle probe. Sci Transl Med. 2014 Oct 29;6(260):260ra149. doi: 10.1126/scitranslmed.3009524. Epub 2014 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 23, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2010)
5
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01266096
Other Study ID Numbers  ICMJE 10-155
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Bradbury, MD,PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP