A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

August 21, 2019 updated by: AHS Cancer Control Alberta

A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT) in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma

The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
  • Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
  • Biochemical parameters as measured are required to be within 5 times the normal limits for age.
  • Able and willing to follow instruction and comply with the protocol
  • Provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale Score 50-100

Exclusion Criteria:

  • Previous removal of entire tumour
  • Biochemical parameters as measured outside 5 times the normal limits for age
  • Unable or unwilling to follow instructions and comply with the protocol
  • Unable or unwilling to provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale Score < 50
  • Nursing or pregnant females
  • Age less than 16 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
18F-FLT PET
Biological: 18F-FLT

Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient.

Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: to determine the safety of 18 F-FLT.
Time Frame: 3 years
3 years
Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase I: To determine general biodistribution of 19F-FLT
Time Frame: 3 years
3 years
Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes.
Time Frame: 3 years
3 years
Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

  • Principal Investigator: Michael B Sawyer, MD, Cross Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2009

Primary Completion (Actual)

February 25, 2019

Study Completion (Actual)

February 25, 2019

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX-FLT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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