Colorectal CancerPhase 2NCT07702292
[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
A Phase 2 study testing [68Ga]BED003 in people with Colorectal Cancer and Epithelial Ovarian Cancer, run by Blue Earth Diagnostics at 6 sites in 2 countries.
Trial summary
This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer (GC)
- What is being tested?
- [68Ga]BED003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Jun 2026to Feb 2028
- Phase
- Phase 2
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [68Ga]BED003 administration.
- Note: If combining screening (Visit 1) and the PET/CT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.
- WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).
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- Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
- Note: Invasive breast cancer with mixed ductal/lobular histology is permitted.
- Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before [68Ga]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
- Either:
- Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.
- Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.
- Suspected recurrence after definitive therapy.
Who cannot join
- Participants administered any radioisotope within 5 physical half-lives prior to [68Ga]BED003 administration.
- Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
- Participants who have recently received any other contrast agent (< 24 hours for IV agents and < 5 days for oral agents) before the day of [68Ga]BED003 administration.
- Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- Known hypersensitivity to [68Ga]BED003 or any of its constituents.
- Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion, including, but not limited to, the following:
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- Any other primary cancers that could confound the interpretation of the study results.
- Major surgery (such as laparoscopy/laparotomy/thoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.
- Serious, non-healing wound, ulcer, or bone fracture.
- Active hepatitis.
- Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.
- Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer (e.g. tumour-associated pancreatitis or biliary stasis for PDAC).
- Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
- Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
- Significant renal impairment, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL/min/1.73m2 or a serum creatinine > 1.5 × the upper limit of normal.
- Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Italy4 sites, 4 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
Paola Erba
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Segrate, 20132
Arturo Chiti
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900
Luca Guerra
- Not yet recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, Roma, 00136
Salvatore Annunziata
Netherlands2 sites, 2 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713
Erik Aarntzen
- Recruiting
Stichting Radboud Universitair Medisch Centrum
Nijmegen, 6525
Martin Gotthardt
About this study
Official title: A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
- Conditions
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer (GC), Pancreatic Ductal Adenocarcinoma (PDAC), Invasive Lobular Breast Carcinoma
- Being tested
- [68Ga]BED003
- Keywords
- Positron emission tomography, Fibroblast activation protein
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Ovarian Epithelial, Stomach Neoplasms, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]BED003Drug
Positron emission tomography (PET)/computed tomography (CT) imaging
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]BED003 | Experimental | Each participant will receive [68Ga]BED003 followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2). Receives: Drug: [68Ga]BED003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Measured: Until completion of follow-up procedures, up to 42 days post injection.
Secondary outcomes (5)
Further assess the diagnostic performance of [68Ga]BED003.
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [68Ga]BED003 PET/CT compared to composite SOT and participant and region level detection rates
Measured: Until completion of follow-up procedures, up to 42 days post injection
Semiquantitative assessment of [68Ga]BED003 tumour uptake.
Standardised uptake values and tumour-to-background ratios.
Measured: Immediately following administration of [68Ga]BED003
Evaluate the safety and tolerability of [68Ga]BED003.
Incidence and severity of adverse events using CTCAE version 5.0.
Measured: From screening until safety follow-up (48 hours post injection).
Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants).
Comparison of tumour-to-background ratios and reader assessments of diagnostic quality.
Measured: Immediately following administration of [68Ga]BED003
Confirm optimal [68Ga]BED003 administered activity (first 6 participants).
Reader assessments of diagnostic quality based on simulated reduced count data.
Measured: Immediately following administration of [68Ga]BED003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start30 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Earth Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702292
- Sponsor's protocol ID
- BED-FAP-201
- Other IDs
- 2025-521983-36-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No