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Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT00606294
Recruitment Status : Active, not recruiting
First Posted : February 1, 2008
Results First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Head and Neck Cancer
Interventions Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
Device: 18F-FMISO PET scan
Device: MRI
Device: FDG PET/CT scan
Enrollment 216
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation. Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
Period Title: Overall Study
Started 197 19
Completed 161 19
Not Completed 36 0
Reason Not Completed
Withdrawal by Subject             36             0
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual) Total
Hide Arm/Group Description Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation. Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery. Total of all reporting groups
Overall Number of Baseline Participants 197 19 216
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 197 participants 19 participants 216 participants
58
(25 to 85)
57
(45 to 70)
58
(25 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 19 participants 216 participants
Female
23
  11.7%
3
  15.8%
26
  12.0%
Male
174
  88.3%
16
  84.2%
190
  88.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 19 participants 216 participants
Hispanic or Latino
8
   4.1%
1
   5.3%
9
   4.2%
Not Hispanic or Latino
189
  95.9%
18
  94.7%
207
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 19 participants 216 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   1.5%
0
   0.0%
3
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   5.1%
0
   0.0%
10
   4.6%
White
166
  84.3%
17
  89.5%
183
  84.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
18
   9.1%
2
  10.5%
20
   9.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 197 participants 19 participants 216 participants
197
 100.0%
19
 100.0%
216
 100.0%
1.Primary Outcome
Title To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Hide Description For Cohort 1
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
This objective is for Cohort 1 participants.
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description:
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
Overall Number of Participants Analyzed 197 0
Measure Type: Count of Participants
Unit of Measure: Participants
Participants who are hypoxia positive
135
  68.5%
0
Participants who are hypoxia negative
26
  13.2%
0
Participants declined scans
36
  18.3%
0
2.Primary Outcome
Title To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
Hide Description For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
This objective is for Cohort 2 participants.
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description:
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
Overall Number of Participants Analyzed 0 19
Measure Type: Count of Participants
Unit of Measure: Participants
Cohort 2 Pts with a Pathologic Complete Response 0
11
  57.9%
Cohort 2 Pts w/out a PathologicComplete Response 0
4
  21.1%
Cohort 2 Participants who were not scanned 0
4
  21.1%
3.Primary Outcome
Title Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Hide Description Cohort 2
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This objective is for Cohort 2 participants.
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description:
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
Overall Number of Participants Analyzed 0 19
Measure Type: Count of Participants
Unit of Measure: Participants
Cohort 2 Pts Negative at Baseline 0
6
  31.6%
Cohort 2 Pts Positive at Baseline at Repeat Scan 0
3
  15.8%
Cohort 2 Pts Negative at Baseline at Repeat Scan 0
9
  47.4%
Cohort 2 Pts positive at Baseline/withdrew consent 0
1
   5.3%
4.Secondary Outcome
Title To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.
Hide Description For Cohort 1
Time Frame 2 weeks from time of scan
Hide Outcome Measure Data
Hide Analysis Population Description
N/A - data were not collected
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description:
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Hide Arm/Group Description Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation. Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
All-Cause Mortality
Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Affected / at Risk (%) Affected / at Risk (%)
Total   47/197 (23.86%)   2/19 (10.53%) 
Hide Serious Adverse Events
Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/197 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 (Closed to Accrual) Cohort 2 (Closed to Accrual)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/197 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nancy Lee, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-3341
EMail: leen2@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00606294    
Other Study ID Numbers: 04-070
First Submitted: January 10, 2008
First Posted: February 1, 2008
Results First Submitted: June 9, 2020
Results First Posted: July 10, 2020
Last Update Posted: July 10, 2020