Trial Outcomes & Findings for A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients (NCT NCT03602911)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From Baseline up to day 7 post imaging

Results posted on

2025-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Proof of Concept The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered 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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proof of Concept n=20 Participants The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered 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
Age, Customized	59.4 years STANDARD_DEVIATION 11.53 • n=20 Participants
Sex: Female, Male Female	2 Participants n=20 Participants
Sex: Female, Male Male	18 Participants n=20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Proof of Concept n=20 Participants The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered 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
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging OP-Primary Tumor	7.21 (SUV) volume (cm3) Standard Deviation 17.00
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging OP-Nodes	4.84 (SUV) volume (cm3) Standard Deviation 17.00
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging OC-Primary Tumor	2.87 (SUV) volume (cm3) Standard Deviation 17.00
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging OC-Nodes	2.46 (SUV) volume (cm3) Standard Deviation 17.00
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging Larynx-Nodes	3.24 (SUV) volume (cm3) Standard Deviation 17.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Proof of Concept n=20 Participants The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered 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
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging OP-Primary Tumor	14.98 (SUV) volume (cm3) Standard Deviation 18.25
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging OP-Nodes	7.59 (SUV) volume (cm3) Standard Deviation 18.25
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging OC-Primary Tumor	13.11 (SUV) volume (cm3) Standard Deviation 18.25
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging OC-Nodes	5.96 (SUV) volume (cm3) Standard Deviation 18.25
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging Larynx-Nodes	3.92 (SUV) volume (cm3) Standard Deviation 18.25

Adverse Events

Proof of Concept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rusha Patel, MD

West Virginia University

Phone: 4052717559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place