Early Phase 1 Head and Neck Cancer Trial, Recruiting NCT05996432 Sponsor: Vanderbilt-Ingram Cancer Center Condition: Head and Neck Cancer
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Early Phase 1 Head and Neck Cancer Trial, Recruiting

NCT05996432
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with head and neck squamous cell carcinoma (a type of cancer in the head or neck area) confirmed by a tissue or cell sample, or who have a clinical diagnosis of brain metastases (cancer that has spread to the brain).
  • People who have at least one tumour that can be measured using a scan or physical examination, meeting minimum size requirements.
  • People who are reasonably active and able to carry out daily activities, as measured by standard health scoring tools (confirm with trial site for exact thresholds).
  • People who are expected to live longer than 6 months.
  • People who are willing and able to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before and shortly after receiving the study imaging agent, if there is any possibility of pregnancy or of fathering a child.
  • People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

  • People who have had allergic reactions to substances chemically similar to the study imaging agent (18F-FMISO).
  • People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements.
  • People whose brain metastases are larger than 3.0 cm (about 1.2 inches).
  • People whose cancer has spread in a way that raises concern for a specific type of spread along the lining of the brain (confirm with trial site).
  • People who have bleeding within the tumour being studied.
  • People who are receiving radiation after surgery to remove brain metastases or a primary head and neck cancer (adjuvant radiotherapy).
  • People with a prior or current brain condition other than brain metastases, including stroke, brain bleeding, Alzheimer's disease or dementia, Parkinson's disease, Multiple Sclerosis, or schizophrenia.
  • People who have previously had radiation treatment in an area that overlaps with the planned treatment area.
  • People who are unable to have an MRI scan due to severe claustrophobia or because they have metal objects or implanted devices in their body, such as a pacemaker, surgical clips, metal fragments, certain implants, or tattoos near the imaging area.
  • People who cannot have an MRI due to weight above 350 lbs (approximately 159 kg), which is a common weight limit for MRI equipment.
  • People who have another existing condition that, in the judgement of the medical team, may increase health risks from participating.
  • People who have a serious ongoing illness or psychiatric or social circumstances that may make it difficult to follow the study requirements.
  • People who are under 18 years of age, or who are currently imprisoned.
  • People who are currently breastfeeding, as the effects of the study imaging agent on infants are unknown.
  • People who are pregnant, as the effects of the study imaging agent on an unborn baby are unknown. Pregnancy testing procedures apply to participants under 60 years of age, following the trial site's guidelines. People who decline pregnancy testing may be asked to sign a waiver confirming they are not known to be pregnant (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Evan Osmundson, MD, PhD, Vanderbilt University/Ingram Cancer Center

Phone: 800-811-8480

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Vanderbilt-Ingram Cancer Center
Registry
ClinicalTrials.gov
Start date
17 May 2023
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov