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

NCT03602911 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1804059675
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging

  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. SUV max of \> 2.5 for 18F-FDG-PET and \> 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern. Using the PET scan, investigators calculated the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.

  From Baseline up to day 7 post imaging

Secondary Outcomes (1)

• Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging

  From Baseline up to day 7 post imaging

Study Arms (1)

Proof of Concept

OTHER

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

Interventions

The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT DRUG

All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging

Proof of Concept

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Medicine

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Rusha Patel, MD
• Organization: West Virginia University

Rusha-Patel@ouhsc.edu

4052717559

Study Officials

• Rusha Patel, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of Concept

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 27, 2018
• Study Start: February 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2023-06

Locations

US (1)