FDG-PET in Advanced Melanoma

NCT02236546 | Terminated Results DMC

• 3 other identifiers: VICC MEL 1372NCI-2014-00179P30CA068485
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, \[18F\]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

Conditions

Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma

Keywords

fluorodeoxyglucose; FDG; PET/CT; melanoma; imaging biomarkers; cancer imaging

Outcome Measures

Primary Outcomes (1)

• Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST

  The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.

  Baseline to the completion of 6 courses of treatment

Secondary Outcomes (3)

• Objective Response (OR)

  Day 84

• Progression-free Survival (PFS)

  Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years

• Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation

  Baseline to day 21

Study Arms (1)

FDG-PET/CT

EXPERIMENTAL

Patients undergo \[18F\]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.

Diagnostic Test: [18F]fluorodeoxyglucose; Other: Molecular assays on biopsied tissue; Device: positron emission tomography; Device: computed tomography

Interventions

[18F]fluorodeoxyglucose DIAGNOSTIC_TEST

FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.

Also known as: 18-F-deoxy-glucose, 18-F-deoxyglucose, FDG, fluorodeoxyglucose F-18

FDG-PET/CT

Molecular assays on biopsied tissue OTHER

Correlative studies

Also known as: immunohistochemistry, genetic assay, laboratory biomarker analysis, molecular profiling, gene expression, tissue microarray

FDG-PET/CT

positron emission tomography DEVICE

Undergo FDG-PET/CT

Also known as: PET, PET scan, tomography, emission computed

FDG-PET/CT

computed tomography DEVICE

CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.

Also known as: CT, tomography, computed

FDG-PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation
• Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
• Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
• Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter

You may not qualify if:

• Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
• Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT
• Subjects incapable of giving informed written consent, for the following reasons:
• Inability to adhere to the experimental protocols for any reason
• Inability to communicate with the research team
• Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
• Prisoners or other individuals deemed to be susceptible to coercion

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Immunohistochemistry; Gene Expression; Tissue Array Analysis; Positron-Emission Tomography; Tomography, Emission-Computed; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Genetic Phenomena; Microarray Analysis; Microchip Analytical Procedures; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Radiographic Image Enhancement; Radiography; Tomography, X-Ray

Results Point of Contact

• Title: Dr. Tom Yankeelov
• Organization: Vanderbilt-Ingram Cancer Center

thomas.yankeelov@utexas.edu

Study Officials

• Tom Yankeelov, PhD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-04

Locations

US (1)