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Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Primary Purpose

Head-and-neck Squamous Cell Carcinoma

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

89Zr-panitumumab IV

Panitumumab

About this trial

This is an interventional diagnostic trial for Head-and-neck Squamous Cell Carcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 19 years.
Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9gm/dL
- White blood cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- PTT = 11.5 - 14.4 seconds
- INR = 0.9 - 1.2

Exclusion Criteria:

Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
History of infusion reactions to other monoclonal antibody therapies
Pregnant or breastfeeding
Magnesium or potassium lower than the normal institutional values
Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Severe renal disease or anuria
Known hypersensitivity to deferoxamine or any of its components

Sites / Locations

Stanford Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

panitumumab 30 mg

89Zr-panitumumab IV

Arm Description

Subjects will be given a 30mg of panitumumab

Subjects will be given 89Zr-panitumumab IV

Outcomes

Primary Outcome Measures

Sensitivity and Specificity of 89Zr-panitumumab

Secondary Outcome Measures

Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging

The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions.

Full Information

NCT ID

NCT05423197

First Posted

June 14, 2022

Last Updated

September 20, 2023

Sponsor

Andrei Iagaru

1. Study Identification

Unique Protocol Identification Number

NCT05423197

Brief Title

Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Official Title

Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrei Iagaru

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

Detailed Description

PRIMARY OBJECTIVE(S): - Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions SECONDARY OBJECTIVE(S): - Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head-and-neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

panitumumab 30 mg

Arm Type

Active Comparator

Arm Description

Subjects will be given a 30mg of panitumumab

Arm Title

89Zr-panitumumab IV

Arm Type

Experimental

Arm Description

Subjects will be given 89Zr-panitumumab IV

Intervention Type

Drug

Intervention Name(s)

89Zr-panitumumab IV

Intervention Description

Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions

Intervention Type

Drug

Intervention Name(s)

Panitumumab

Intervention Description

Panitumumab 30mg will be given orally

Primary Outcome Measure Information:

Title

Sensitivity and Specificity of 89Zr-panitumumab

Description

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging

Description

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 19 years. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed. Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions. Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results: Hemoglobin ≥ 9gm/dL White blood cell count > 3000/mm3 Platelet count ≥ 100,000/mm3 Serum creatinine ≤ 1.5 times upper reference range PTT = 11.5 - 14.4 seconds INR = 0.9 - 1.2 Exclusion Criteria: Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment History of infusion reactions to other monoclonal antibody therapies Pregnant or breastfeeding Magnesium or potassium lower than the normal institutional values Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis Severe renal disease or anuria Known hypersensitivity to deferoxamine or any of its components

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roan C Raymundo, BS

Phone

(650) 721-4071

rcraymun@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Grace Yi

Phone

650-723-1423

gracesyi@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judy Nguyen, MD

Organizational Affiliation

Stanford Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Cancer Institute

City

San Francisco

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roan C Raymundo, BS

Phone

650-721-4071

rcraymun@stanford.edu

First Name & Middle Initial & Last Name & Degree

Grace Yi

Phone

650-723-1423

gracesyi@stanford.edu

First Name & Middle Initial & Last Name & Degree

Judy Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Yu-Jin Lee, MD, MS

First Name & Middle Initial & Last Name & Degree

Andrei Iagaru, MD

First Name & Middle Initial & Last Name & Degree

Carina Aparici, MD

First Name & Middle Initial & Last Name & Degree

Guido Davidzon, MD

First Name & Middle Initial & Last Name & Degree

Farshad Moradi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Benjamin L Franc, MD, MS, MBA

First Name & Middle Initial & Last Name & Degree

Jagruti Shah, MBBS

First Name & Middle Initial & Last Name & Degree

Saad Khan, MD

First Name & Middle Initial & Last Name & Degree

Dimitrios Colevas, MD

First Name & Middle Initial & Last Name & Degree

Fred Baik, MD

First Name & Middle Initial & Last Name & Degree

Chris Holsinger, MD

First Name & Middle Initial & Last Name & Degree

Vasu Divi, MD

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

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