Pancreatic CancerEarly Phase 1NCT05141643
Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer
A Early Phase 1 study testing PET Scan in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- PET Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 18 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically-confirmed (confirmed at MSKCC) PDAC
- Patients must be ≥ 18 years old
- Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- Karnofsky Performance Status ≥70%.
- Life expectancy ≥3 months.
- A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.
Who cannot join
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
- Being tested
- PET Scan
- Keywords
- Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanDiagnostic test
Also called 18F-FAC PET Scan
Participants will receive a minimum of 4 mCi (148 MBq) and up to a maximum of 10 mCi (370 MBq) of [18F]-FAC intravenously. Injection is performed in conjunction with a dynamic PET acquisition over a site of the disease (pre-selected based on the findings from a previous CT or MRI and FDG PET/CT study done for clinical purpose such as staging). Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
| Study group | Role | What they receive |
|---|---|---|
| Participants with pancreatic ductal adenocarcinoma (PDAC) | Experimental | Participants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single [18F]-FAC PET scan prior to the administration of chemotherapy with an optional second [18F]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional. Receives: Diagnostic Test: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline
Measured: Baseline
Secondary outcomes (1)
changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.
To investigate changes in [18F]-FAC drug uptake and distribution during or following SOC chemo- and/or radiation therapy. Based on those patients who agree to undergo the second optional [18F]-FAC PET scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start18 Nov 2021
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heiko Schoder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141643
- Sponsor's protocol ID
- 21-442
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT05141643
- Acronym / sponsor ID
- 21-442
- Keywords
- Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with pancreatic ductal adenocarcinoma (PDAC) | Experimental | Diagnostic Test: PET ScanParticipants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single [18F]-FAC PET scan prior to the administration of chemotherapy with an optional second [18F]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically-confirmed (confirmed at MSKCC) PDAC
- Patients must be ≥ 18 years old
- Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- Karnofsky Performance Status ≥70%.
Key exclusion criteria (2 listed)
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ScanAlso: 18F-FAC PET ScanParticipants will receive a minimum of 4 mCi (148 MBq) and up to a maximum of 10 mCi (370 MBq) of [18F]-FAC intravenously. Injection is performed in conjunction with a dynamic PET acquisition over a site of the disease (pre-selected based on the findings from a previous CT or MRI and FDG PET/CT study done for clinical purpose such as staging). Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional. | Diagnostic test | Participants with pancreatic ductal adenocarcinoma (PDAC) |
Primary outcome
Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
Time frame: Baseline
The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline
1 secondary outcome
changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiko Schoder, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET Scan in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor drug uptake within PDAC tumors prior at pre-treatment baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.