ClinicalTrials.gov
ClinicalTrials.gov Menu

[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01717391
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : September 5, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Uterine Cervical Neoplasms
Endometrial Neoplasms
Anus Neoplasms
Rectal Neoplasms
Prostatic Neoplasms
Intervention: Drug: fluorothymidine F 18

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FLT PET/CT

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.


Participant Flow:   Overall Study
    FLT PET/CT
STARTED   36 
COMPLETED   27 
NOT COMPLETED   9 
Withdrawal by Subject                5 
Physician Decision                1 
FLT technical failure                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FLT PET/CT

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.


Baseline Measures
   FLT PET/CT 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      29  80.6% 
>=65 years      7  19.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      24  66.7% 
Male      12  33.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   36 


  Outcome Measures

1.  Primary:   Percent Difference From Baseline IMRT Plan (%)   [ Time Frame: Baseline (pre-treatment) ]

2.  Secondary:   Chemotherapy Compliance   [ Time Frame: At 24 months ]

3.  Secondary:   Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts   [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment ]

4.  Secondary:   Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.   [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment ]

5.  Secondary:   Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)   [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment ]

6.  Secondary:   Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.   [ Time Frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John M. Buatti, MD
Organization: The University of Iowa
phone: 319-356-2699
e-mail: john-buatti@uiowa.edu


Publications of Results:
Other Publications:

Responsible Party: John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier: NCT01717391     History of Changes
Other Study ID Numbers: 201204712
R01CA169336 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 2012
First Posted: October 30, 2012
Results First Submitted: June 30, 2017
Results First Posted: September 5, 2017
Last Update Posted: July 31, 2018