Prediction of tumour uptake of therapeutic docetaxel using [11C]docetaxel and PET-CT

Docetaxel is an important chemotherapeutic agent in the treatment of several
cancer types. However, tumour resistance to docetaxel remains a major
challenge. Since positron emission tomography (PET) and radiolabelled
anticancer agents provide a unique means for personalized treatment planning,
the new PET tracer [11C]docetaxel was developed by labelling the drug docetaxel
with the short-lived positron-emitting radionuclide carbon-11. [11C]docetaxel
uptake may be predictive of tumour response and thereby offer a means of
avoiding ineffective, but toxic treatment in individual patients. For other
radiolabelled anticancer agents, however, it has been demonstrated that the
therapeutic dose can affect the tumour uptake of the tracer dose. Therefore,
the effect of the therapeutic dose of the drug docetaxel on [11C]docetaxel
uptake by tumours should be investigated.

1) To study whether [11C]docetaxel uptake by tumours predicts tumour uptake of
therapeutic docetaxel.
2) To study the effects of therapeutic docetaxel on venous metabolite fractions
of [11C]docetaxel.
3) To study the relation between tumour blood flow and [11C]docetaxel uptake in
tumours after administration of therapeutic docetaxel.

An observational study with invasive measurements. The procedure consists of a
low dose CT scan, intravenous administration of [15O]H2O and [11C]docetaxel,
PET acquisition for about 70 min and venous blood sampling during PET scanning.
This procedure will be repeated on the same day. During the second PET scan the
therapeutic dose of docetaxel will be administered.

Risks associated with participation in this study are related to 1) radiation
exposure; 2) idiosyncratic reaction to the tracer [11C]docetaxel; 3)
intravenous cannulation; 4) blood sampling; 5) discomfort during scanning; 6)
administration therapeutic docetaxel.

1) Radiation exposure
The total amount of radiation burden is 6 mSv.

2) Idiosyncratic reaction to the tracer [11C]docetaxel
No [11C]docetaxel-induced side-effects are expected.

3) Intravenous cannulation
There is a very small risk of infection, bleeding or hematoma.

4) Blood sampling
The total amount of blood taken for investigation is 160 ml.

5) Discomfort during scanning
It may be uncomfortable to lie motionless in the PET camera and it may cause
some subjects to feel anxious.

6) Administration of therapeutic docetaxel
Docetaxel treatment can cause several side-effects. For a complete overview of
docetaxel-induced side-effect we refer of the SPC of docetaxel.