First-in-human testing of FID-022 in solid tumor patients
AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
This project will test an AI tool to spot early cancer-related weight loss and see if diet and exercise support are acceptable for people with newly diagnosed pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07249775 on ClinicalTrials.gov |
What this trial studies
This observational effort combines retrospective records from the Florida Pancreas Collaborative with prospective enrollment of newly diagnosed pancreatic cancer patients at Moffitt Cancer Center. Researchers will validate a multimodal AI model that uses clinical, imaging, and lifestyle data to detect early cancer-associated cachexia. Enrolled participants will complete baseline lifestyle and symptom assessments, extended lifestyle monitoring, and a feasibility survey about diet and exercise interventions. The study will describe how well the AI predicts early weight and muscle loss and whether patients find the proposed nutritional and activity supports practical and acceptable.
Who should consider this trial
Good fit: Adults (≥18) with histologically or clinically confirmed pancreatic exocrine cancer, ECOG 0-2, able to take oral nutrition, able to read and speak English, and likely to receive systemic therapy are the intended participants.
Not a fit: People who are pregnant or breastfeeding, currently receiving enteral or parenteral nutrition, or with medical conditions such as significant ascites that preclude accurate assessment may not receive benefit from the interventions tested.
Why it matters
Potential benefit: If successful, the project could enable earlier detection of cachexia and support timely diet/exercise approaches that may preserve weight, strength, and quality of life.
How similar studies have performed: Related predictive-modeling work and nutrition/exercise programs for cancer cachexia have shown mixed but encouraging early results, while multimodal AI specifically applied to pancreatic cancer cachexia remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period. * Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease * May or may not have had surgery * Treatment plan likely includes systemic therapy for pancreatic cancer * ECOG performance status 0-2 * Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition * Able to read and speak English * Able to provide written informed consent Exclusion Criteria: * Pregnant or breastfeeding at the time of enrollment * Current use of tube feeding (enteral) or total parenteral nutrition * Presence of ascites or other findings suggestive of decompensated disease * Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake * Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation * Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ghulam Rasool, PhD — Moffitt Cancer Center
- Study coordinator: Sanjukta Bhattacharjee
- Email: Sanjukta.Bhattacharjee@moffitt.org
- Phone: 813-745-0279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.