Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proof of Concept | Other | The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT 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. |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rusha Patel, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Medicine | Morgantown | West Virginia | 26501 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Standard Deviation | (SUV) volume (cm3) | From Baseline up to day 7 post imaging |
|
6 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rusha Patel, MD | West Virginia University | 4052717559 | Rusha-Patel@ouhsc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2017 | Jun 29, 2023 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2017 | Jun 29, 2023 | ICF_004.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
Not provided
Not provided
Not provided
Proof of Concept
Not provided
Not provided
Not provided
Not provided
| From Baseline up to day 7 post imaging |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT 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. | Posted | Median | Standard Deviation | (SUV) volume (cm3) | From Baseline up to day 7 post imaging |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| Title | Measurements |
|---|---|
|
| OC-Nodes |
|
| Larynx-Nodes |
|