CT-scans and Clinical Trials

[Guest guest]

I have some good news, at least from the Cancer Center

at OSU. On my last monitoring visit I had to sign a new

Consent Order for my participation in the PCI-32765

monotherapy Trial which contained an updated list of side

effects and it was noted that there would be a decrease in

the frequency of scanning from the previous protocol. I wish

I could take credit for this welcome change but Dr.

Byrd has expressed the need for fewer scans when I raised

the issue prior to my enrollment. Fewer scans does not mean

foregoing them when a particular patient's disease warrants

a scan.

Quoting from a recent posting: " Due to the problems with a

drug in a trial, my husband is being asked to do his 5th CT

scan in 10 months. I do not see any reason for this scan

since he had one just a month and a half ago and little has

changed. " .....Snip...

Given a pre trial scan and three more spaced two months

apart an oncologist should be on top of any changes

requiring the need for another scan at the 10 month mark. In

this instance the Doc should provide a PATIENT SPECIFIC

reason for a scan and not just a generalized " problems with

a drug " reason if that was what had been given. One scenario

could be aggressive internal lymphadenopathy that is

threatening blood supply or nerve function to a vital organ

that could justify more frequent scanning.

Language for the new Consent form addressing scanning at the

Cancer Clinic for my PCI Trial reads under pre Trial

Screening " You will have a CT scan ...Snip... " Change from

previous Consent form eliminates the possible requirement

for " PET or combined CT/PET scanning " which is reasonable

and a good move.

Under Cycle 2 (56 days out from starting drug) it reads " You

will have a CT scan ...Snip... " Change from previous Consent

form eliminates the possible requirement for " PET or

combined CT/PET scanning " which is good but I still wonder

if it is too soon from the previous Screening scan for every

patient?

Under Cycles 5, 8, 12, 18 and 24 it reads " ... you MAY

(emphasis mine) have a CT scan, or a physical exam to check

on the cancer. " Change from previous Consent form again

eliminates the possible imposition of having a required PET

or combination CT/PET scan. Reasonable and the " MAY " should

give you, the patient some wiggle room to debate with your

Doc the reason for having a CT scan at any one of these

cycles.

I am heading into my Cycle 5 visit and in my marching

orders, there is no scheduled CT scan. Thank you Dr. Byrd!

If you do not like the scanning schedule you or your loved

one is on, consider an activist action that I have taken by

adding to your Consent form the words " under protest of

frequent scanning " This will not disqualify you from Trial

participation but lets your Onc, the drug companies and

hopefully the FDA know that the Lab Rats are restless!

We at the are fortunate in having Byrd for a PI

(Principle Investigator) for I believe he is on our side in

this effort to reduce unnecessary scanning. You may not be

so fortunate but you should make your concerns known in

writing at your facility. This does not in any way end the

Doc's judicial use of scans when there is a suspected need.

A suspected need should be well explained to the patient.

Power to the Lab Rats!

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