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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


Phase 1/Phase 2
16 Years
N/A
Open (Enrolling)
Both
Brain Cancer, Cancer, Solid Tumor, Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Phase I: to determine the safety of 18 F-FLT.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Alexander J. B. McEwan, MB, BS, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute

Authority:

Canada: Health Canada

Study ID:

SP-24513/DX-FLT-002

NCT ID:

NCT01065805

Start Date:

February 2009

Completion Date:

December 2015

Related Keywords:

  • Brain Cancer
  • Cancer
  • Solid Tumor
  • Lymphoma
  • 18F-FLT
  • Positive Emission Tomography
  • Cancer
  • Brain Neoplasms
  • Lymphoma
  • Neuroendocrine Tumors

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