Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 20, 2018 |
| End Date: | December 20, 2021 |
| Contact: | Austin Pantel, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
We plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced
pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16
weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to
participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to
receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical
care.
A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed
tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.
PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using
the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT
PET/CT will not be used to direct treatment decisions. While patients and referring
physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be
made by the treating physicians based upon clinical criteria.
Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of
injection of [18F]FTT. This procedure will be followed by a skull base to mid-thigh scan,
starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an
injection of approximately 10 mCi (approximate range for most studies is anticipated to be
8-12 mCi) of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of
pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.
All 30 evaluable patients are expected to start PARP inhibitor therapy following the [18F]FTT
PET/CT scan. It is expected that due to patient preference and time considerations,
approximately 24 patients (80%) will also undergo a second (optional) scan that will be
performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is
obtained to evaluate whether the PARP inhibitor therapy decreases [18F]FTT uptake, which
would suggest PARP blocking by the therapy.
pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16
weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to
participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to
receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical
care.
A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed
tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.
PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using
the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT
PET/CT will not be used to direct treatment decisions. While patients and referring
physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be
made by the treating physicians based upon clinical criteria.
Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of
injection of [18F]FTT. This procedure will be followed by a skull base to mid-thigh scan,
starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an
injection of approximately 10 mCi (approximate range for most studies is anticipated to be
8-12 mCi) of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of
pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.
All 30 evaluable patients are expected to start PARP inhibitor therapy following the [18F]FTT
PET/CT scan. It is expected that due to patient preference and time considerations,
approximately 24 patients (80%) will also undergo a second (optional) scan that will be
performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is
obtained to evaluate whether the PARP inhibitor therapy decreases [18F]FTT uptake, which
would suggest PARP blocking by the therapy.
Inclusion Criteria:
- Participants will be ≥ 18 years of age.
- Histologically proven pancreatic adenocarcinoma. .
- Deemed to have achieved stability following ≥16 weeks of platinum based therapy, in
the opinion of an investigator
- Considered a candidate for PARP inhibitor therapy, with or without additional agents,
either on a clinical trial or as part of clinical care.
- Participants must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines prior
to study-specific procedures.
Exclusion Criteria:
- Females who are pregnant or breast feeding at the time of screening will not be
eligible for this study; a urine pregnancy test will be performed in women of
child-bearing potential at screening.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician
- Serious or unstable medical or psychological conditions that, in the opinion of the
investigator, would compromise the subject's safety or successful participation in the
study.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Austin Pantel, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
Click here to add this to my saved trials
