NCT04840472

Brief Summary

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma. The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
28

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline
10mo left

Started Mar 2021

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2021Mar 2027

Study Start

First participant enrolled

March 30, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

5.9 years

First QC Date

April 7, 2021

Last Update Submit

December 17, 2025

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.

    Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type.

    15 days

Secondary Outcomes (2)

  • Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye

    10 days after surgery

  • Compare specificity of systemic 111In panitumumab versus conventional local optical dye

    10 days after surgery

Study Arms (1)

111-In panitumumab

EXPERIMENTAL

The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.

Drug: 111I-n panitumumabProcedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans

Interventions

111I-n panitumumabDRUG

Imaging Agent

111-In panitumumab
Single photon emission computed tomography/computed tomography (SPECT/CT) scansPROCEDURE

Day 1 to 5 (Day of Surgery inclusive)

111-In panitumumab

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
  • Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.
  • Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count \> 3000/mm3
  • Platelet count ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 times upper reference range

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Fred Baik, MD

    Stanford Universiy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

March 30, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)