Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

Head and Neck Cancer Clinical Trial

Official title:

A Phase II/III, Open Label, Non-Randomized, Multi-Center Study of Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00894101
• Other study ID #: HS# 2009-6857
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: July 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient provides written Informed Consent and is willing to comply with protocol requirements

2. Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)

3. Patient is capable of lying still in the PET scanner for the protocol required time frame(s)

4. Patient has a diagnosis of one of the following malignancies (TNM Staging System):

• Lung cancer (T3 grade up, node positive, but no metastatic disease)

• Head and neck cancer (T3 grade up, node positive, but no metastatic disease)

5. Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas

6. Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent

7. As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18] FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)

8. Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan

9. Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)

10. Patient has a score of greater than or equal to (=) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

1. Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:

• by testing on site at the institution (serum or urine ßHCG) within 48 hours prior to the start of each investigational product administration,

• by surgical history (eg, tubal ligation or hysterectomy),

• by patient's history of being post menopausal with a minimum 1 year without menses.

2. Patient is undergoing treatment with palliative intent

3. Patient has received an investigational compound and/or medical device within 14 days before admission into this study

4. Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations

5. Patient is determined by the Investigator that he/she is clinically unsuitable for the study.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• [F-18] FLT
10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.

Locations

Country	Name	City	State
United States	Department of Radiology, UCI Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG.		1 year