Head and Neck Squamous Cell Carcinoma study: 18F-fluoromisonidazole
Official title Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
ClinicalTrials.gov ID: NCT05996432
What this study is testing
What is 18F-fluoromisonidazole?
18F-fluoromisonidazole is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will apply novel MRI approaches with established sensitivity to tissue oxygen consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as tumor recurrence and progression post-treatment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed head and neck squamous cell carcinoma or a clinical diagnosis of CNS-excluded nervous system neoplasm and...
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for...
- ECOG performance status \ /=70%
- Life expectancy of greater than 6 months
- The effects of 18F-FMISO on the developing human fetus are unknown.
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FMISO
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Brain metastases \>3.0 cm
- Dural-based metastases concerning for leptomeningeal disease
- Hemorrhage within the lesion of interest
- Patients presenting for radiation after surgical resection of brain metastasis/metastases or primary head and neck cancer (adjuvant radiotherapy)
See the full eligibility criteria
- Histologically or cytologically confirmed head and neck squamous cell carcinoma or a clinical diagnosis of CNS-excluded nervous system neoplasm and disorder (brain metastases)
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions, minimum size 7mm)...
- ECOG performance status \ /=70%
- Life expectancy of greater than 6 months
- The effects of 18F-FMISO on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control
- Ability to understand and the willingness to sign a written informed consent document
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FMISO
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Brain metastases \>3.0 cm
- Dural-based metastases concerning for leptomeningeal disease
- Hemorrhage within the lesion of interest
- Patients presenting for radiation after surgical resection of brain metastasis/metastases or primary head and neck cancer (adjuvant radiotherapy)
- Prior or current known history of disease involving the brain other than brain metastases and including but not limited to
- Prior overlapping radiation fields
- Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts...
- Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
- Presence of serious systemic illness, including uncontrolled intercurrent infection or psychiatric/social situations which may limit compliance with study requirements
- Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit for the MRI table)
- Prisoners, children \<18 years of age
- Prior overlapping radiation fields
- Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts...
- Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
- Presence of serious systemic illness, including uncontrolled intercurrent infection or psychiatric/social situations which may limit compliance with study requirements
- Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit for the MRI table)
- Prisoners, children \<18 years of age
- The effects of 18F-FMISO on the developing infant are unknown. For this reason, nursing women will be excluded from the trial Pregnant patients which will be identified as follows;
- Patients over the age of 60 do not require a pregnancy test per institutional guidelines. We anticipate this to be most of our patient population due to the age distribution of cancer patients.
- Patients under the age of 60 will be offered a point of care pregnancy test when seen in consult at the department of Radiation Oncology.
- Patients refusing pregnancy testing can sign a waiver stating that they refuse pregnancy testing but that they are not known to be pregnant
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.