← Back to Search

Zr-Panitumumab Imaging for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Judy Nguyen, MD
Research Sponsored by Andrei Iagaru
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 19 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will test if 89Zr-panitumumab can help find metastatic HNSCC lesions.

Who is the study for?
Adults over 19 with a confirmed diagnosis of head and neck squamous cell carcinoma, including those with recurrent disease or new primary. They must have had a PET/CT scan within the last 30 days showing suspected metastatic lesions and meet certain blood, kidney, and liver function criteria. Excluded are pregnant/breastfeeding individuals, those with low magnesium/potassium levels, severe renal issues, known allergies to similar drugs, lung conditions like interstitial pneumonitis or pulmonary fibrosis, or recent significant cardiovascular events.Check my eligibility
What is being tested?
The trial is testing the effectiveness of an intravenous drug called Zr-Panitumumab in detecting metastatic cancer lesions in patients with head and neck cancers when used alongside standard PET/CT scans.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the monoclonal antibody therapy (Zr-Panitumumab), which could manifest as infusion reactions. There's also a risk for individuals with sensitivities to deferoxamine or its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 19 years old or older.
Select...
My blood, kidney, and liver tests are within the required ranges.
Select...
I have been diagnosed with squamous cell carcinoma in my head or neck.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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

Side effects data

From 2020 Phase 1 & 2 trial • 166 Patients • NCT01750918
69%
Dermatitis acneiform
61%
Nausea
58%
Diarrhoea
56%
Dry skin
50%
Fatigue
44%
Pyrexia
44%
Vomiting
39%
Paronychia
39%
Pruritus
36%
Decreased appetite
31%
Constipation
28%
Oedema peripheral
25%
Erythema
25%
Skin fissures
22%
Stomatitis
22%
Rash maculo-papular
22%
Rash
22%
Anaemia
22%
Hypomagnesaemia
19%
Dysgeusia
19%
Weight decreased
17%
Abdominal pain upper
17%
Asthenia
17%
Chills
17%
Mucosal inflammation
17%
Hypoalbuminaemia
14%
Hypocalcaemia
14%
Hypertrichosis
14%
Aspartate aminotransferase increased
14%
Dyspepsia
14%
Back pain
14%
Dyspnoea
11%
Abdominal pain
11%
Haematuria
11%
Folliculitis
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypophosphataemia
11%
Dry eye
11%
Dry mouth
11%
Hypokalaemia
11%
Muscle spasms
11%
Insomnia
11%
Cough
8%
Abdominal distension
8%
Urinary tract infection
8%
Hypertension
8%
Malaise
8%
Arthralgia
8%
Hypotension
6%
C-reactive protein increased
6%
Renal failure
6%
Palpitations
6%
Xerosis
6%
Pustule
6%
Oedema
6%
Peripheral swelling
6%
Skin infection
6%
Limb injury
6%
Skin laceration
6%
Blood creatinine increased
6%
Blood lactate dehydrogenase increased
6%
Papule
6%
Dehydration
6%
Lacrimation increased
6%
Ocular hyperaemia
6%
Trichomegaly
6%
Vision blurred
6%
Cheilitis
6%
Flatulence
6%
Gastrooesophageal reflux disease
6%
Erysipelas
6%
Tinea pedis
6%
Upper respiratory tract infection
6%
Flank pain
6%
Hirsutism
6%
Syncope
6%
Taste disorder
6%
Hyperkeratosis
6%
Productive cough
6%
Rhinorrhoea
6%
Onycholysis
6%
Pain of skin
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Orthostatic hypotension
6%
Myalgia
6%
Pain in extremity
3%
Sepsis
3%
Anal haemorrhage
3%
Hyperkalaemia
3%
Pulmonary embolism
3%
Gamma-glutamyltransferase increased
3%
Protein total decreased
3%
Hair growth abnormal
3%
Supraventricular tachycardia
3%
Basal cell carcinoma
3%
Herpes zoster
3%
Nasopharyngitis
3%
Rash pustular
3%
Respiratory tract infection
3%
Dermatitis
3%
Hand dermatitis
3%
Hot flush
3%
Headache
3%
Blood alkaline phosphatase increased
3%
Body temperature increased
3%
Colitis
3%
Enteritis
3%
Large intestinal stenosis
3%
Pancreatitis
3%
Small intestinal perforation
3%
Non-cardiac chest pain
3%
Escherichia urinary tract infection
3%
Staphylococcal sepsis
3%
Urinary tract infection bacterial
3%
Subdural haematoma
3%
Lung disorder
3%
Stevens-Johnson syndrome
3%
Influenza like illness
3%
Nail infection
3%
Oral candidiasis
3%
Oral herpes
3%
Hyperglycaemia
3%
Dizziness
3%
Epistaxis
3%
Eczema
3%
Skin papilloma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 4.8MG/KG Q2W
Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 2MG QD, PAN 6MG/KG Q2W
Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 6MG/KG Q2W
Part 4A+4B - Double Combination (T+P): TRA 1.5MG QD, PAN 6MG/KG Q2W
Part 4A+4B - Double Combination (T+P): TRA 2MG QD, PAN 4.8MG/KG Q2W
Part 1+2A - Double Combination (D+P): DAB 150MG BID, PAN 6MG/KG Q2W
Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 4.8MG/KG Q2W
Part 1+2A+2B - Triple Combination (T+D+P): DAB 150MG BID, TRA 1.5MG QD, PAN 6MG/KG Q2W

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 89Zr-panitumumab IVExperimental Treatment1 Intervention
Subjects will be given 89Zr-panitumumab IV
Group II: panitumumab 30 mgActive Control1 Intervention
Subjects will be given a 30mg of panitumumab

Find a Location

Who is running the clinical trial?

Andrei IagaruLead Sponsor
15 Previous Clinical Trials
536 Total Patients Enrolled
Judy Nguyen, MDPrincipal InvestigatorStanford Cancer Institute

Media Library

89Zr-panitumumab IV Clinical Trial Eligibility Overview. Trial Name: NCT05423197 — Phase 2
Head and Neck Cancers Research Study Groups: panitumumab 30 mg, 89Zr-panitumumab IV
Head and Neck Cancers Clinical Trial 2023: 89Zr-panitumumab IV Highlights & Side Effects. Trial Name: NCT05423197 — Phase 2
89Zr-panitumumab IV 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423197 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being accepted into this trial?

"This particular clinical trial is not currently looking for patients, as shown on clinicaltrials.gov. This page was created on June 1st, 2022 and last updated two weeks later on June 14th, 2022. Although this study isn't recruiting right now, there are 2761 other trials that are presently seeking candidates."

Answered by AI

Has the FDA given the go-ahead to use 89Zr-panitumumab IV?

"89Zr-panitumab IV's efficacy has not been proven in clinical trials, but there is evidence that it is safe. Power gave it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Andrei Iagaru 2024. "Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05423197.
~40 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top