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When used with a different radioactive tracer called FMISO, a PET scan can find areas of low oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are hard to treat with radiation.
In a past study, FMISO PET scans were performed in 6 patients with rectal cancer that could not be operated on and that had spread to other areas. In this group of patients, FMISO PET scans were able to find the low oxygen areas in their tumors. But this study included only a few patients. In the present study, we want to use FMISO PET scans in patients who have tumors that can be operated on. This group of patients will have radiation, chemotherapy or both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in this distinct group of patients.
Hypoxia is a characteristic feature of malignant solid tumors associated with poor prognosis and resistance to chemotherapy and radiation. It has also been shown (6) that the presence of hypoxia may reduce long-term survival post surgery. Hypoxia renders tumor cells up to three times more resistant to ionizing radiation than aerobic cells. The presence of hypoxic regions within tumors may be one factor leading to local failure after treatment with standard pre-operative radiotherapy doses. If these regions could be identified and verified using a non-invasive imaging technique prior to surgery, they could be specifically targeted using sophisticated planning techniques such as intensity modulated radiation therapy (IMRT) to deliver higher doses ionizing radiation with preoperative radiotherapy. Future studies using IMRT to "dose paint" areas of hypoxia within tumors will build upon the results of this feasibility study. Ultimately, by the delivery of differential dose of radiation to the tumor, in combination with surgery, the local control rates of rectal cancer patients may further be improved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FMISO PET study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission | Radiation | You will be scanned 2 to 3 times on the same day, but you will only be administered one dose of the FMISO tracer. The first scan will last about 30 minutes. Then you will have 1 to 3 hours to wait before you are scanned again. Some patients will undergo a second scan approximately one-and-a-half hours after the start of the first scan. This scan will last about 10 minutes. The final scan will occur between 2-4 hours after the start of the first scan. This final scan will also last about 10 minutes. During the PET scan, you may have a separate i.v. line put into your other arm so that we can take 2 to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how quickly FMISO leaves your blood stream. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken with each subsequent scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Successfully Scanned Using F-FMISO-PET Imaging | The uptake kinetics of [18F]-Fluoromisonidazole activity in the colorectal lesion was entered into a compartmental model to determine the rate constants of uptake (k1) and irreversible binding (k3) in the lesion on the PET scan at different times post injection. Also the tumor to background ratio was determine. A plot of k3 and TNB was plotted. This will help determine the Feasibility of a Non-invasive Method of Detecting Hypoxia, Using F-FMISO-PET Imaging in Colorectal Cancer Patients. | Post injection between 0-30 min, and again at the nominal times of 90 min and 180 min |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Blood Samples Collected | Blood sample was taken in order to determine the blood pharmacokinetics of [18F]-Fluoromisonidazole in these participants. | Up to 180 minutes post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Humm, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | FMISO PET Study | FMISO PET study. Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2020 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FMISO PET Study | FMISO PET study. Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Successfully Scanned Using F-FMISO-PET Imaging | The uptake kinetics of [18F]-Fluoromisonidazole activity in the colorectal lesion was entered into a compartmental model to determine the rate constants of uptake (k1) and irreversible binding (k3) in the lesion on the PET scan at different times post injection. Also the tumor to background ratio was determine. A plot of k3 and TNB was plotted. This will help determine the Feasibility of a Non-invasive Method of Detecting Hypoxia, Using F-FMISO-PET Imaging in Colorectal Cancer Patients. | Posted | Count of Participants | Participants | Post injection between 0-30 min, and again at the nominal times of 90 min and 180 min |
|
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had Blood Samples Collected | Blood sample was taken in order to determine the blood pharmacokinetics of [18F]-Fluoromisonidazole in these participants. | Posted | Count of Participants | Participants | Up to 180 minutes post injection |
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180 minutes post injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMISO PET Study | FMISO PET study. Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Humm, PhD | Memorial Sloan Kettering Cancer Center | 212-639-7367 | hummj@MSKCC.ORG |
| Dec 5, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title |
|---|
| Denominators |
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| Categories |
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