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New treatment option for Esophageal Cancer
Official title Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy
ClinicalTrials.gov ID: NCT04846309
What this study is testing
What is FMISO PET CT?
FMISO PET CT is an investigational medicine, being studied as a potential treatment for esophageal cancer.
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 is a Phase I trial evaluating the safety of personalized radiation therapy based on levels of hypoxia identified on FMISO-PET and MRI. All patients will receive a baseline FMISO positron emission tomography (PET) and MRI to identify levels of hypoxia.
- 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
- Male or female subject aged ≥ 18 years.
- Esophageal cancer patient eligible to undergo either neoadjuvant or definitive chemoradiation therapy (CRT). Note: Stage IV patients with limited...
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- For female people: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been...
- Women \< 50 years of age:
You likely can't join if
- Unable to undergo an MRI for any reason, including:
- Severe claustrophobia not amenable to pre-medication
- Presence of metallic objects or implanted medical devices in the body that are not MRI-compatible (e.g., non-MRI-compatible cardiac pacemaker, deep...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how...
- The subject has severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for chemoradiation...
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety...
See the full eligibility criteria
- Male or female subject aged ≥ 18 years.
- Esophageal cancer patient eligible to undergo either neoadjuvant or definitive chemoradiation therapy (CRT). Note: Stage IV patients with limited metastatic disease burden may be eligible if CRT is recommended by the...
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- For female people: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following...
- Women \< 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses \>1 year ago; or
- Had chemotherapy-induced menopause with last menses \>1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Recovery to baseline or ≤ Grade 2 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Unable to undergo an MRI for any reason, including:
- Severe claustrophobia not amenable to pre-medication
- Presence of metallic objects or implanted medical devices in the body that are not MRI-compatible (e.g., non-MRI-compatible cardiac pacemaker, deep brain stimulator, neurostimulator, aneurysm clips, surgical clips...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the radiation therapy are eligible for this...
- The subject has severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for chemoradiation therapy.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Known HIV infection with a detectable viral load at the time of screening.
- Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.
- Known prior severe hypersensitivity to gadolinium, FMISO or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, 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 - 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?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.