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A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT03602911
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Rusha Patel, West Virginia University

Brief Summary:
This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT Phase 2

Detailed Description:
Patients meeting inclusion criteria will be consented at the time of scheduling. All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging with the AAA-provided dose. These scans will be performed no less than 8 hours, no more than 7 days apart. For patients undergoing same-day imaging, NETSPOT imaging will be performed prior to 18F-FDG-PET/CT. Following imaging, both 18F-FDG-PET/CT and NETSPOT imaging will be compared by trained neuroradiologists for SUV values and concordance with known sites of disease. Biopsies will be performed as is standard to verify all sites of primary or metastatic disease. Patients with oropharyngeal tumors will have HPV testing performed via the standard of care surrogate marker p16. Patients with p16-positive tumors will be recorded and analyzed separately for the above measures. Patients will be followed for a total of 1 year after the study and outcomes of overall survival, disease-free survival, presence and site of recurrence and development of metastatic disease will be recorded. All gathered data will be compared between reported 18F-FDG-PET/CT and NETSPOT imaging for true positive, true negative, positive predictive value and negative predictive value of patient groups.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Proof of Concept
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019


Arm Intervention/treatment
Proof of Concept
The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered
Drug: The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT
All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging




Primary Outcome Measures :
  1. Detection and Staging of Head and Neck Squamous Cell Carcinoma [ Time Frame: 6 months ]
    NETSPOT imaging will be at least equivalent to 18F FDG PET/CT in the detection and staging of HNSCC. This will be done using Standard Uptake Value (SUV) measurements.


Secondary Outcome Measures :
  1. Detection of primary site for Head and Neck Squamous Cell Carcinoma [ Time Frame: 6 months ]
    The Combination of NETSPOT imaging and 19F FDG PET/CT will have increased specificity for detecting the primary site for HNSCC of unknown primary than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements.

  2. Detection of disease recurrence and metastasis following treatment [ Time Frame: 6 months ]
    The combination of NETSPOT imaging and 18F FDG PET/CT, will have increased specificity for detecting disease recurrence and metastasis following treatment than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with suspected or diagnosed HNSCC undergoing planned 18F FDG PET/CT at the time of primary diagnosis or after completion of treatment.

Exclusion Criteria:

Inability to undergo 18F-FDG-PET/CT imaging due to medical comorbidities


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602911


Contacts
Contact: Aimie Jones, CCRC 304- 598-6135 jonesai@wvumedicine.org
Contact: Rusha Patel, MD rusha.patel@hsc.wvu.edu

Locations
United States, West Virginia
West Virginia University Medicine Not yet recruiting
Morgantown, West Virginia, United States, 26501
Contact: Aimie Jones, CCRC         
Principal Investigator: Rusha Patel, MD         
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Rusha Patel, MD West Virginia University

Responsible Party: Rusha Patel, Assistant Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03602911     History of Changes
Other Study ID Numbers: 1137154
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Fluorodeoxyglucose F18
Radiopharmaceuticals