- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791594
Imaging FDG Flare in Melanoma
Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The subject must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
- The subject must be ≥ 18 years of age on day of signing informed consent.
- The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.
- The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
- The subject must be recommended to start pembrolizumab.
Exclusion Criteria:
- Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
- Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.
- Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.
- Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.
- Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Subject has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) as determined by medical record review.
- Subject has known active central nervous system metastases and/or carcinomatous meningitis.
Note: Subjects with previously treated brain metastases will be eligible to participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to receiving pembrolizumab and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of complete response or partial response or nonresponders (stable disease or progressive disease) to CT.
Time Frame: 6 months
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Response will be determined by RECIST version 1.1.
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 02616
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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