Dr. Michael
J.
Welch
Professor of Radiology Co-Director Div of Radiological Scien
Washington University School of Medicine St. Louis
510 S. Kingshighway Blvd
Saint Louis, MO 63110
Phone: 314-362-8436
Fax: 314-362-8399
E-mail: welchm@wustl.edu
Number of Human Subjects projects reported: 2
| WASHU-06-Cu-ATSM | "Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides: Comparison of 60Cu-ATSM PET with 64Cu-ATSM PET in Cervical Cancer " |
| WASHU-07-Pilot FFNP | "Labeling of Receptor Ligands and Other Compounds with Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) using FFNP " |
"Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides: Comparison of 60Cu-ATSM PET with 64Cu-ATSM PET in Cervical Cancer"
Principal Investigator: Dr. Farrokh Dehdashti, Washington University
Project started in: 2006
Status of the Research this Fiscal Year:
Study is no longer enrolling and participants have completed all research-related interventions. The study remains active only for long-term follow-up.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Washington University
Most recent approval: 12/14/06
IRB approval number: 05-1161
Explanation of IRB approval:
Current IRB expiration is 12/13/2007. Request for renewal has been submitted to the IRB but not yet approved. Initial approval was from 1/25/2006 through 1/24/2007.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Other: 01/25/06 to 09/28/07
Explanation:
Includes all subjects entered since initial IRB approval.
Type(s) of Human Subjects Involvement:
The goal is to develop a hypoxia-based imaging method for assessment of tumor hypoxia that can be readily adopted by medical centers lacking access to a cyclotron. The primary objective is to assess the quality of 60Cu-ATSM imaging as compared to 64Cu-ATSM imaging in subjects with a new diagnosis of cervcial carcinoma. (ATSM is Diacetyl-bis[N4-methylthiosemicarbozone].) Subjects are exposed to ionizing radiation from the intravenous injection of 60Cu-ATSM, 64Cu-ATSM, and from 68Ge/68Ga transmission rod sources. Subjects undergo two positron emission tomography (PET) scans on separate occasions after intravenous injection of 60Cu-ATSM and 64Cu-ATSM. Vital signs and laboratory (complete blood count, comprehensive metabolic panel blood test, and urinalysis) safety analysis occurs for each subject. Risks are limited to radiation exposure, discomfort from placement of an intravenous line, and discomfort from lying still on the imaging table. All subjects signed informed consent prior to any research studies and have the option to quit at any time. Images and associated paperwork are available only to study personnel. Participation and results are not part of the subjects' medical records.
"Labeling of Receptor Ligands and Other Compounds with Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) using FFNP"
Principal Investigator: Dr. Farrokh Dehdashti, Washington University
Project started in: 2007
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: WU FFNP Pilot
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Washington University
Most recent approval: 04/02/07
IRB approval number: 06-1034
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Other: 01/03/07 to 10/17/07
Explanation:
Start date of initial IRB approval includes all subjects currently in the study.
Type(s) of Human Subjects Involvement:
The goal is to develop a non-invasive imaging method for assessment of tumor progesterone receptor (PR) status in newly diagnosed breast cancer patients. The primary objects are to: 1) Assess the diagnostic quality of FFNP-PET imaging at the proposed 10 mCi dose. 2) Quantitatively determine the relationship between tumor FFNP uptake and in-vitro status of PR. 3) Calculate human dosimetry. (FFNP is 21-[18F]Fluoro-16alpha,17alpha-[(R)-1'- alpha -furylmethylidene)dioxy]-19-norpregn-4-ene-3,20 dione.) Subjects are exposed to ionizing radiation from the intravenous injection of 18F-FFNP and from 68Ge/68Ga transmission rod sources.
Dosimetry subjects undergo two whole body positron emission tomography (PET) scans and, if they can tolerate the extra imaging, two additional static images centered over their tumor. Vital signs, electrocardiogram, and laboratory (complete blood count, comprehensive metabolic panel blood test, progesterone levels, and urinalysis) safety analysis occurs for each subject. Risks are limited to radiation exposure, discomfort from placement of an intravenous line, and discomfort from lying still on the imaging table. All subjects sign informed consent prior to any research studies and have the option to quit at any time. Images and associated paperwork are available only to study personnel. Participation and results are not part of the subjects' medical records.