Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy

NCT02608528 | Terminated DMC

• 1 other identifier: UPCC 15515
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer. Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with clinical markers of response. PET/CT tumor metabolic response will also be correlated will to progression-free survival and overall survival.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Number of inflammatory changes within the tumor

  2 years

Interventions

[18F]fluoroglucose(FDG) RADIATION

Eligibility Criteria

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

Study Population

Adult men and women of any ethnicity with NSCLC deemed unresectable by CT or PET imaging criteria and planning to start anti-PD1/PDL1 therapy.

You may qualify if:

• Adult patients, at least 18 years of age
• Histologically confirmed non-small cell lung cancer or malignancy pleural mesothelioma with at least one site of disease \> 1 cm by at least one type of standard imaging (e.g.
• CT, chest x-ray, MRI)
• Recommended to start anti-PD1/PDL1 therapy.
• Obtaining pre-PD1/PDL1 therapy clinical re-staging \[18F\]FDG-PET/CT scan at the Hospital of the University of Pennsylvania.
• 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.
• Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.

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 pregnancy test at the time of the screening visit.
• Patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
• Patients who have received prior immunotherapy.
• Patients with an active auto-immune disease (ie. Multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, vasculitis).
• 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.
• Unwilling or unable to provide informed consent

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sharyn Katz, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 18, 2015
• Study Start: October 22, 2015
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

US (1)