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A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (FLT101)

Primary Purpose

Lung Cancer, Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[F-18]FLT
Sponsored by
Siemens Molecular Imaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, head and neck cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, FLT, [F-18]FLT, FDG, [F-18]FDG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 βHCG) 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.

Sites / Locations

  • Hoag Memorial Hospital
  • Excel Diagnostics Imaging Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT PET scan

Arm Description

Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.

Outcomes

Primary Outcome Measures

[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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2009
Last Updated
July 26, 2013
Sponsor
Siemens Molecular Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT00847509
Brief Title
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Siemens Molecular Imaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Head and Neck Cancer
Keywords
lung cancer, head and neck cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, FLT, [F-18]FLT, FDG, [F-18]FDG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLT PET scan
Arm Type
Experimental
Arm Description
Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
Intervention Type
Drug
Intervention Name(s)
[F-18]FLT
Other Intervention Name(s)
[F-18] FLT, FLT
Intervention Description
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.
Primary Outcome Measure Information:
Title
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
Description
The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.
Time Frame
3-5 weeks after the start of radiation or chemo radio therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 βHCG) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebrahim S Delpassand, MD
Organizational Affiliation
Excel Diagnostics Imaging Clinics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Brandt-Zawadzki, MD
Organizational Affiliation
Hoag Memorial Hospital, Newport Beach, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Excel Diagnostics Imaging Clinics
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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