Early FDG PET in Melanoma

NCT02716077 | Terminated DMC

• 1 other identifier: UPCC 11615
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients with histologically proven melanoma who will be treated with pembrolizumab will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated with lab and pathology results.

Conditions

Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  3 years

Study Arms (1)

Single arm

EXPERIMENTAL

FDG PET/CT scan pre-therapy

Radiation: FDG PET/CT imaging

Interventions

FDG PET/CT imaging RADIATION

Single arm

Eligibility Criteria

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

You may qualify if:

• Adult patients, at least 18 years of age
• History of histologically confirmed melanoma as assessed per medical record review.
• Eligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
• Participants 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.

You may not qualify if:

• 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 or serum pregnancy test at the time of the screening visit.
• Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
• Ineligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
• Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Michael Farwell, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (1)