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PET Imaging for Head and Neck Cancer and Brain Cancer
Phase 1
Waitlist Available
Led By Mariam S Aboian, MD PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with resectable squamous cell carcinoma of the oropharynx (HPV positive and HPV negative).
Patients with brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from with in 2 weeks perioperative up to postoperative
Awards & highlights
Study Summary
This trial will test a new, non-invasive way to measure PD-L1 levels in cancer patients, and will also compare it to the current standard method.
Who is the study for?
This trial is for adults with head and neck cancers or brain metastases, who have a tumor size of at least 1 cm and are candidates for surgery. They must have normal organ function tests, including kidney and liver tests, and women must test negative for pregnancy. People with blood counts outside the specified range cannot participate.Check my eligibility
What is being tested?
The study is testing a new PET scan tracer called adnectin 18F-BMS-986192 to measure PD-L1 levels non-invasively in patients with head and neck cancer or brain metastases. It will be compared to traditional methods after surgical removal of tumors.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the PET tracer such as discomfort at injection site, allergic reactions, or exposure to radiation from the imaging process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of throat cancer that can be surgically removed.
Select...
My cancer has spread to my brain.
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My tumor is at least 1 cm in size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from with in 2 weeks perioperative up to postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from with in 2 weeks perioperative up to postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-invasive quantitative PD-L1 levels will be measured using PET measures (VT) of lesions for the groups of PD-L1 levels (PD-L1 ≥90% vs <1%, PD-L1 ≥50% vs <1%) in head and neck cancer primary lesions
Secondary outcome measures
Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes
Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer primary lesion
Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes
+1 moreOther outcome measures
Immunohistochemistry vs PET measure of PD-L1 levels within resected brain metastasis tumor cells
Trial Design
2Treatment groups
Experimental Treatment
Group I: Head and neck cancerExperimental Treatment1 Intervention
Participants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection.
Group II: Brain MetastasesExperimental Treatment1 Intervention
Participants with metastases to the brain from melanoma, lung cancer, breast cancer.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,521 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,146 Total Patients Enrolled
Mariam S Aboian, MD PhDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have enough white blood cells, red blood cells, and platelets in your body.My cancer has spread to my brain.Your creatinine levels are not too high (5 times the normal limit or lower).If you are a woman who could become pregnant, you need to have a negative pregnancy test within a week before treatment.Your albumin level must be above 0 grams per deciliter (a measure of blood protein).My tumor is at least 1 cm in size.I have a type of throat cancer that can be surgically removed.A surgeon has confirmed that my tumor can be surgically removed.My cancer is HPV-related, confirmed by a specific p16 test.Your liver function tests must show that your levels of AST and ALT are less than five times the upper limit of normal, and your bilirubin levels must be less than 1.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Head and neck cancer
- Group 2: Brain Metastases
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned 18F-BMS-986192 Head and Neck Cancer with adnectin?
"Since this Phase 1 trial has limited data confirming the safety and efficacy of adnectin 18F-BMS-986192 Head and neck cancer, it was given a score of 1 on our rating scale."
Answered by AI
Is the research project currently seeking participants?
"In accordance with clinicaltrials.gov, this particular trial is not in the process of actively recruiting participants. This research was first posted on November 1st 2022 and last revised October 10th 2022. However, there are currently 592 other medical studies that require volunteers to enroll right now."
Answered by AI
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