A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation

Lung Cancer Clinical Trial

— FLT101  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847509
• Other study ID #: FLT101
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: July 26, 2013
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2013
• Source: Siemens Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.

Description:

PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images

Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

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

• Patient has a diagnosis of one of the following malignancies using the 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)

• 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

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

• 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)

• 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

• Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)

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

Exclusion Criteria:

• Patient is a pregnant or lactating female. 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

• Patient is undergoing treatment with palliative intent

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

• 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

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

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer

Intervention

Drug:
• [F-18]FLT
The individual doses of [F-18]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Locations

Country	Name	City	State
United States	Excel Diagnostics Imaging Clinics	Houston	Texas
United States	Hoag Memorial Hospital	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan	The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.	3-5 weeks after the start of radiation or chemo radio therapy	No