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NCT03602911

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

Completed Phase 2 Results posted Last updated 12 March 2025
What this trial tests

Phase 2 trial testing The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma in 20 participants. Completed in 1 April 2021.

Timeline
1 February 2019
Primary endpoint
1 April 2021
1 April 2021

Quick facts

Lead sponsorWest Virginia University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment20
Start date1 February 2019
Primary completion1 April 2021
Estimated completion1 April 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

West Virginia University

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging Primary · From Baseline up to day 7 post 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.

OP-Primary Tumor
GroupValue95% CI
Proof of Concept7.21± 17.00
OP-Nodes
GroupValue95% CI
Proof of Concept4.84± 17.00
OC-Primary Tumor
GroupValue95% CI
Proof of Concept2.87± 17.00
OC-Nodes
GroupValue95% CI
Proof of Concept2.46± 17.00
Larynx-Nodes
GroupValue95% CI
Proof of Concept3.24± 17.00
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging Secondary · From Baseline up to day 7 post imaging

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. 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, radiologists can calculate the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.

OP-Primary Tumor
GroupValue95% CI
Proof of Concept14.98± 18.25
OP-Nodes
GroupValue95% CI
Proof of Concept7.59± 18.25
OC-Primary Tumor
GroupValue95% CI
Proof of Concept13.11± 18.25
OC-Nodes
GroupValue95% CI
Proof of Concept5.96± 18.25
Larynx-Nodes
GroupValue95% CI
Proof of Concept3.92± 18.25

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

Other West Virginia University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03602911.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing